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Effects of isolated soluble fiber supplementation on body weight,

glycemia, and insulinemia in adults with overweight and obesity: a


systematic review and meta-analysis of randomized controlled trials
Sharon V Thompson,1 Bridget A Hannon,1 Ruopeng An,1,2 and Hannah D Holscher1–3
1
Division of Nutritional Sciences, and Departments of 2Kinesiology and Community Health and 3Food Science and Human Nutrition, University of Illinois,
Urbana, IL

ABSTRACT INTRODUCTION
Background: There is strong epidemiologic evidence that dietary Overweight and obesity are substantial public health challenges. A
fiber intake is protective against overweight and obesity; however,

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majority of adults in the United States are now overweight or obese
results of intervention studies have been mixed. Soluble fiber ben- (1), and in 2010, excess weight was connected with $316 billion in
eficially affects metabolism, and fiber supplementation may be a health care costs (2). The fiscal impact of overweight and obesity is
feasible approach to improve body composition and glycemia in exacerbated by heightened risks of detrimental physical and mental
adults with overweight and obesity. health conditions as well as all-cause mortality (3, 4). Epidemiologic
Objective: We evaluated randomized controlled trials (RCTs) of
data have strongly linked dietary fiber consumption with reduced risk
isolated soluble fiber supplementation in overweight and obese
of obesity (5–7). The result of intervention studies, which have
adults on outcomes related to weight management [body mass index
used a range of different types and amounts of fibers, have been
(BMI; in kg/m2), body weight, percentage of body fat, and waist
mixed but have generally shown body-composition and meta-
circumference] and glucose and insulin metabolism (homeostasis
bolic improvements (8–14).
model assessment of insulin resistance and fasting insulin)
In May 2016, the Food and Drug Administration issued a defi-
through a systematic review and meta-analysis.
nition of dietary fiber that governs which fibers may be included on a
Design: We searched PubMed, Web of Science, Cumulative Index to
Nursing and Allied Health Literature and Cochrane Library databases.
Nutrition or Supplement Facts Label, and fiber was defined as
Eligible studies were RCTs that compared isolated soluble fiber with nondigestible carbohydrates $3 monomeric units that are inherent
placebo treatments without energy-restriction protocols. Random- in food and isolated or synthetic fibers with shown physiologic
effects models were used to estimate pooled effect sizes and 95% benefits (15, 16). Dietary fiber is a 2015–2020 Dietary Guidelines
CIs. Meta-regressions were performed to assess outcomes in relation for Americans nutrient of public health concern because con-
to the intervention duration, fiber dose, and fiber type. Publication bias sumption barely surpasses 50% of adequate intake recommenda-
was assessed via Begg’s and Egger’s tests and funnel plot inspection. tions (17–22). The contrast between adequate intake, which is based
Results: Findings from 12 RCTs (n = 609 participants) from 2 to on the protective impact of fiber against coronary artery disease, and
17 wk of duration are summarized in this review. Soluble fiber
supplementation reduced BMI by 0.84 (95% CI: 21.35, 20.32;
P = 0.001), body weight by 2.52 kg (95% CI: 24.25, 20.79 kg; Supported by the University of Illinois College of Agricultural, Consumer
and Environmental Sciences (Jonathan Baldwin Turner Fellowship; to SVT),
P = 0.004), body fat by 0.41% (95% CI: 20.58%, 20.24%; P , 0.001),
the Agriculture and Food Research Initiative (competitive grant 2015-68001-
fasting glucose by 0.17 mmol/L (95% CI: 20.28, 20.06 mmol/L;
23248 from the USDA National Institute of Food and Agriculture; to BAH),
P = 0.002), and fasting insulin by 15.88 pmol/L (95% CI: 229.05, and the USDA National Institute of Food and Agriculture (hatch project
22.71 pmol/L; P = 0.02) compared with the effects of placebo ILLU-698-902; to HDH). This is a free access article, distributed under
treatments. No publication bias was identified. Considerable terms (http://www.nutrition.org/publications/guidelines-and-policies/license/)
between-study heterogeneity was observed for most outcomes. that permit unrestricted noncommercial use, distribution, and reproduction in
Conclusions: Isolated soluble fiber supplementation improves anthro- any medium, provided the original work is properly cited.
pometric and metabolic outcomes in overweight and obese adults, Supplemental Tables 1 and 2 and Supplemental Figures 1–3 are available
thereby indicating that supplementation may improve fiber intake and from the “Online Supporting Material” link in the online posting of the ar-
health in these individuals. However, the interpretation of these findings ticle and from the same link in the online table of contents at http://ajcn.
nutrition.org.
warrants caution because of the considerable between-study heterogene-
Address correspondence to HDH (e-mail: hholsche@illinois.edu).
ity. This trial was registered at clinicaltrials.gov as NCT03003897. Am J
Abbreviations used: MQS, Heyland Methodologic Quality Score; RCT,
Clin Nutr 2017;106:1514–28. randomized controlled trial; SMD, standardized mean difference.
Received June 22, 2017. Accepted for publication October 2, 2017.
Keywords: body composition, glucose, insulin, meta-analysis, soluble First published online November 1, 2017; doi: https://doi.org/10.3945/
fiber supplementation ajcn.117.163246.

1514 Am J Clin Nutr 2017;106:1514–28. Printed in USA. Ó 2017 American Society for Nutrition

Supplemental Material can be found at:


http://ajcn.nutrition.org/content/suppl/2017/11/01/ajcn.117.1
63246.DCSupplemental.html
SUPPLEMENTAL FIBER IMPROVES WEIGHT AND GLYCEMIA 1515
actual intake is even greater in adults with obesity (17, 19). Cereals supplementation alone on outcomes of interest, we evaluated the
are the predominant source of dietary fiber in US diets and are fol- provision of supplemental soluble fiber in the absence of other
lowed by more meager proportions that are obtained from vegetable interventions. Thus, studies that involved whole-food treatments
and fruit sources (19, 22, 23). Because dietary fiber that is obtained or high-fiber–profile diets and weight-loss protocols that used
from whole foods (e.g., inherent in food) remains grossly inadequate, counseling or energy restriction were excluded.
enhancing the fiber content of the food supply via supplementation of
isolated or synthetic fibers with known physiologic benefits may be a Search strategy
feasible strategy to improve fiber intake and health (24, 25).
Dietary fibers are heterogeneous, and their physicochemical We located peer-reviewed articles in 4 electronic bibliographic
properties (e.g., solubility, viscosity, and fermentability) in- databases including PubMed, (www.ncbi.nlm.nih.gov/pubmed),
fluence therapeutic consumption effects (26). Soluble fiber intake Web of Science (www.wokinfo.com), the Cumulative Index to
has been linked to increased satiety and improved blood lipid Nursing and Allied Health Literature (www.ebscohost.com/
concentrations and glycemic response. Putative mechanisms for nursing/products/cinahl-databases/the-cinahl-database), and
these metabolic benefits include elevated bile-acid excretion and Cochrane Library (www.thecochranelibrary.com) databases
appetite-suppressing hormones and incretin hormone changes from database initiation through 26 January 2017 using the
that delay nutrient absorption and gastric emptying (27–30). search strategy described in Supplemental Table 1. After ac-
Furthermore, emerging research suggests that fiber fermentation quiring the initial search results, titles and abstracts of articles
by the gastrointestinal microbiota and increased luminal con- were evaluated for suitability against study-selection criteria.
centrations of microbial fermentation end products (e.g. short- Full-text articles were retrieved and assessed for inclusion. A
chain fatty acids) may also impact energy intake and absorption, cited reference search (forward reference search) and a reference

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body weight, and glycemic control (31–36). list search (backward reference search) were conducted on the
The impetus for this study was to systematically identify and basis of the eligible articles that were identified from the key-
quantitatively evaluate the efficacy of isolated soluble fiber word search. Articles that were identified through the forward
supplementation on body composition and glucose and insulin and backward reference searches were screened and evaluated
homeostasis in overweight and obese adults. We hypothesized with the use of the same study selection criteria. Our reference
that soluble fiber supplementation would improve glucose and search was repeated on all newly identified articles until no
insulin concentrations and reduce BMI (in kg/m2), body weight, additional relevant articles were found. Two raters (SVT and
body fat, and waist circumference independent of energy BAH) separately determined the inclusion or exclusion of all
restriction. articles that were retrieved for a full-text evaluation, and dis-
agreements in categorical assignment (yes or no) were resolved
through a consensus. The interrater agreement for the full-text
METHODS search was evaluated with the use of Cohen’s k.

Study selection criteria Data extraction


Systematic review and meta-analysis procedures were We extracted the following information from included studies:
conducted in accordance with the Cochrane Handbook for author, publication year, study design, soluble fiber–intervention
Systematic Reviews of Interventions and reported according duration, soluble fiber dosage, study population and eligibility,
to Preferred Reporting Items for Systematic Reviews and Meta- numbers of participants who were analyzed at baseline and at
Analyses guidelines (37, 38). The study protocol was registered the end of the treatment period (study completers), treatment
at clinicaltrials.gov as NCT03003897. We included peer- group size, outcomes measured, and intervention effectiveness.
reviewed randomized controlled trials (RCTs) involving partic- Outcomes of interest included those that are related to body
ipants who were 1) adults aged $18 y; 2) overweight or obese composition including BMI, body weight, percentage of body
[BMI $25.0 for US populations or $23.0 for Asian populations fat, and waist circumference as well as biomarkers of glucose
(39) or with a waist circumference $40 inches (94 cm) in men and insulin homeostasis including fasting glucose and insulin,
or $35 inches (80 cm) in women or a waist-to-hip ratio $0.90 glycated hemoglobin, the Matsuda index, and the HOMA-IR
in men or $0.85 in women] (40); 3) weight stable and not actively (41). All relevant outcome data were extracted regardless of
trying to lose weight at screening; and 4) without physician- whether these data were analyzed within the primary studies.
diagnosed chronic conditions at screening (e.g., hypertension,
type 2 diabetes, and cardiovascular disease). We included
studies that involved comparison groups who received either a Meta-analysis
placebo without soluble fiber or an isolated soluble fiber treat- We conducted a meta-analysis when $2 studies reported means
ment as part of controlled consumption studies or ad libitum– and variance data for similar outcomes of interest. Measures of
supplementation interventions that were conducted in free-living central tendency were included in the meta-analysis as published
subjects. We excluded studies that met any of the following or approximated if raw data were unable to be obtained by study
criteria: studies conducted in animals, mechanistic research, or authors. Treatment-group data were pooled for the 2 studies that
human trials involving children; conference proceedings; arti- included high and low treatment dosages (42, 43).
cles not published in English; studies #1 wk in duration; and All units of measure were converted to standard International
studies that pooled outcome-measure data for healthy weight System units before inclusion in the meta-analysis. Data that
individuals and those with overweight and obesity. Because the were collected at baseline and at the end of the respective
objective of this meta-analysis was to explore the efficacy of treatment periods were incorporated in the meta-analysis. We
1516 THOMPSON ET AL.

assessed the between-study heterogeneity of soluble fiber–in- from the Cochrane Library) (Figure 1). After duplicate abstracts
tervention effects using the I2 statistic (44). The following I2 were removed, a total of 7013 abstracts remained, in which 6824
interpretive categories were used: ,30% was considered low were excluded on the basis of the article title and abstract
heterogeneity, 30–75% was considered moderate heterogeneity, screening. We included 189 articles in the full-text review dur-
and .75% was deemed considerable heterogeneity (38, 44). A ing which 174 articles were excluded for not meeting study-
random-effects model was used as the default method to esti- selection eligibility criteria. In the excluded articles, 30 studies
mate pooled effects and 95% CIs. This model was used instead were ,1 wk in duration (47–76); 3 studies included a duplicate
of a fixed-effects model because of the observed variation in study population as had been evaluated in other articles (77–79);
study treatments and protocols (38). We conducted meta- 14 studies provided ineligible study treatments (78, 80–90); 23
regressions to assess outcomes in relation to the following 3 studies provided dietary fiber to both treatment and placebo
prespecified factors: intervention duration, daily dose of soluble groups (91–113); 2 studies only included normal-weight adults
fiber, and soluble fiber category. Factors were selected on the (114, 115); 11 studies reported central-tendency measures for
basis of the likelihood of influence on outcomes of interest. The participants who were not solely in the overweight or obese
intervention duration was defined as the time period (weeks) categories (115–125); 11 studies were published in languages
when participants received the treatment or placebo; the soluble other than English (126–136); 8 studies were conference pro-
fiber dose was defined as daily grams of fiber treatment as ceedings (137–144); 9 studies reported nonrelevant outcomes
provided during the intervention; and the categorization of sol- (145–152); 5 studies involved participants with previously di-
uble fibers was based on their physicochemical properties agnosed and currently treated metabolic disease (153–157); 48
[e.g., 1) soluble, viscous, and fermentable or 2) soluble, non- studies were review papers (18, 26, 29, 159–203); and 10 studies
viscous, and fermentable]. Studies that provided .1 dose of included energy restriction or weight-loss programs in addition

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soluble fiber and interventions that mixed multiple soluble fiber to fiber supplementation (204–213). Three studies met our in-
types were excluded from the meta-regressions. The meta- clusion criteria but were unable to be included in the meta-
analysis was conducted with RevMan version 5.3.5 software analysis because of the presentation of geometric means and
(The Nordic Cochrane Center, The Cochrane Collaboration). SEs or an absence of pretreatment and posttreatment data for
Meta-regression and publication-bias analyses were performed study completers (214–216). One RCT was identified and in-
with Stata version 14.1 software (StatCorp LP). P # 0.05 was cluded in the review after the forward and backward searches
accepted as statistically significant. (217). We included this study despite the use of current weight
as a percentage of ideal body weight for participant screening as
Sensitivity analysis opposed to BMI or other anthropometric measures listed in the
pre-established study inclusion criteria. Interrater agreement was
Study outliers were identified through a sensitivity analysis in 94%, and Cohen’s k was 0.70, indicating substantial agreement
which pooled effects of the meta-analysis were calculated after between raters (218).
the systematic sequential removal of individual studies. A study
was considered to be an outlier if, on omission, the pooled-effect
size changed .10% (45). Study and participant characteristics
Characteristics of the included studies are summarized in
Study quality and risk of bias assessment Table 1. We included a total of 12 studies with 609 participants
that were published between 1984 and 2016 and assessed sol-
We evaluated study quality using the Heyland Methodologic
uble fiber supplementation in overweight and obese, but other-
Quality Score (MQS). This instrument quantifies study methodo-
wise healthy, adults in the meta-analysis. All included studies
logic quality on the basis of 9 criteria, including random assignment,
were placebo-controlled RCTs with intervention durations
analysis, blinding, patient selection, baseline group compara-
ranging from 2 to 17 wk. Data were analyzed for subjects who
bility, extent of follow-up, treatment protocol, co-interventions,
were measured at baseline and posttreatment time points. Eleven
and outcomes (46). Included studies were given a score between
(92%) of the 12 trials had parallel-arm designs (42, 43, 217,
0 (lowest quality) and 14 (highest quality), and those with a score
219–226), and 2 studies (17%) administered multiple doses of
$8 were considered high-quality trials. The Cochrane Risk of
soluble fiber (42, 43). A 4-wk washout period was used for the
Bias tool was used to evaluate study bias according to the fol-
crossover study (227). All included studies incorporated a
lowing 7 domains: sequence generation, allocation concealment,
nonfiber placebo treatment. Placebo-treatment vehicles were
blinding of participants, blinding of personnel, outcome assess-
identical to those for the soluble fiber treatment (n = 4; 33%)
ment, incomplete outcome data, selective reporting, and other
(42, 220, 223, 226) or included added maltodextrin (n = 5; 42%)
potential sources of bias (38). The MQS and Cochrane Risk of
(43, 219, 222, 224, 227), starch (n = 2; 17%) (217, 221), or rice
Bias Tool were used to measure the strength of study evidence
flour (n = 1; 8%) (225). One study provided dried glucose syrup
and potential bias but did not determine study inclusion.
in addition to the placebo treatment (223). Three trials (25%)
involved solely female participants (217, 219, 220), and 2 trials
RESULTS (17%) (221, 222) involved only male participants. Four studies
(33%) were conducted in Asian populations (221–223, 225).
Study selection Primary outcomes for the included studies included measures
We identified a total of 9204 potentially eligible articles from that were related to body composition in 8 studies (217, 220–
keyword search (4381 articles from PubMed, 3221 articles from 222, 224–227) and to glucose or insulin in 8 studies (42, 219–
the Web of Science, 748 articles from CINAHL, and 854 articles 222, 224, 225, 227). One study specifically evaluated fiber
SUPPLEMENTAL FIBER IMPROVES WEIGHT AND GLYCEMIA 1517

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FIGURE 1 Study search and selection summary. Articles were identified from (www.ncbi.nlm.nih.gov/pubmed), the Web of Science (www.wokinfo.
com), the Cumulative Index to Nursing and Allied Health Literature (www.ebscohost.com/nursing/products/cinahl-databases/the-cinahl-database), and the
Cochrane Library (www.thecochranelibrary.com) and through forward and backward searches of articles that were assessed during the full-text evaluation.

tolerance (220), and 3 studies included measures of energy in- provided a varied mix of viscous and nonviscous fermentable fi-
take or appetite as primary outcomes (43, 223, 224). Fiber- bers. Baseline total dietary fiber intakes were reported and were
intake compliance was high (85–100%) when reported and shown to be similar between treatment and placebo groups in 3 of
was evaluated in 8 studies through in-person observations (222), the 12 included studies (43, 223, 225). One study presented
packet returns (43, 224, 225), or self-reported consumption re- baseline intake values that were greater than the mean US intake
cords (42, 43, 219, 220, 225, 226). (31.6 g/d for both treatment and control groups) with the use of
The types of soluble fiber treatments and daily dosages varied data from one 24-h dietary recall (223); a second study reported
in studies. One study (220) administered individualized dosages intakes that were similar to mean US consumption values
of soluble fiber on the basis of body weight, and the remaining (i.e., w16–17 g/d) at baseline but did not include the methodology
studies provided daily soluble fiber treatments between 3 and 34 g. for how these data were collected (43); and a third study reported
Six of the included studies included soluble fiber treatments #10 g/d mean baseline dietary fiber intakes of 9.6 g/d for both treatment
(42, 217, 219, 221, 226, 227), and 5 studies included treatments and placebo groups with the use of data from 7-d diet records
between 15 and 34 g soluble fiber/d (43, 222–225). Two studies (225). Measures of energy intake were reported in 8 studies (67%)
provided 2 doses of soluble fiber (42, 43). Five (42%) of the 12 (43, 220–225, 227), 3 of which observed significant reductions in
included studies provided nonviscous but fermentable fiber intake in the treatment group compared with in the placebo group
supplements in the form of manno-oligosaccharides, galacto- (222–224). Four studies (33%) used additional screening pro-
oligosaccharides, and fructo-oligosaccharides (220, 223, 224, cedures to include individuals without a previous diagnosis of
226, 227). Five studies (42%) used fiber treatments that were re- metabolic disease but with elevated glucose (42, 221), lipids
ported to be soluble, viscous, and fermentable (42, 217, 219, 222, (220), or metabolic syndrome risk factors (227) at screening.
225). Four of these studies used individual fiber types including
b-glucan (42), flaxseed mucilage (219), mannans (225), and a
proprietary formulation consisting of wheat and maize-derived Study quality and biases
dextrin (222). One study (43) administered a 50:50 mixture of All but one of the included studies [i.e., Walsh et al. (217)]
pectin (a soluble, viscous, fermentable fiber) and oligofructose (a could be considered high quality according to the MQS (Table 1,
soluble, nonviscous, fermentable fiber), and another study (221) Supplemental Table 2). Two studies reported the use of
TABLE 1
Details of RCTs (n = 12) included in the meta-analysis1
1518

Baseline fiber Duration, Outcome measures


Study, year (ref) Study design Fiber treatment Placebo treatment Dose intake, g/d wk MQS Study population Sample size, n evaluated

Bays et al., 2011 (42) DB, parallel arm Barley b-glucan in flavored Flavored water beverage HD: 6 g/d Not reported 12 9 30–70 y old 44 4 Glucose
water beverage without fiber LD: 3 g/d BMI (in kg/m2): 25–40 HD treatment: 15 Y Insulin, HD
LD treatment: 15 Y HOMA-IR, HD
Placebo: 14
Brahe et al., 2015 (219) SB, parallel arm Flaxseed mucilage in Breakfast buns with 10 g/d Not reported 6 8 Women aged 40–70 y 39 4 Glucose
breakfast buns maltodextrin BMI: 30–45 Treatment: 19 4 Insulin
Placebo: 20 4 HOMA-IR
Genta et al., 2009 (220) DB, parallel arm Fructo-oligosaccharide in syrup Sugar-free syrup without 0.14 g/kg Not reported 17 8 Women aged 31–49 y 35 Y Weight
fiber BMI $30 Treatment: 20 Y BMI
Placebo: 15 Y Body fat percentage
Y WC
4 Glucose
Y Insulin
Y HOMA-IR
Kobayakawa et al., DB, parallel arm Galactomannan, glucomannan, Powdered starch without 7.5 g/d Not reported 12 9 Asian men aged 20–65 y 30 Y Weight
2013 (221) b-glucan, and alginic acid fiber in water BMI ,35 with visceral obesity Treatment: 15 Y BMI
powder in water Placebo: 15 Y Glucose
Li et al., 2010 (222) DB, parallel arm Soluble dextrin from maize and Fruit juice with 34 g/d Not reported 12 10 Asian men aged 20–35 y 120 Y Weight
wheat starch in fruit juice maltodextrin BMI .24 Treatment: 60 Y BMI
Placebo: 60 Y Body fat percentage
4 Glucose
4 Insulin
Y HOMA-IR
Morel et al., 2015 (223) DB, parallel arm Galacto-oligosaccharide in tea Tea and glucose syrup 18 g/d Treatment: 31.6 2 11 Asian adults aged 18–45 y 44 Y Weight
without fiber Placebo: 31.6 BMI: 25–28 Treatment: 22 Y BMI
Placebo: 22 4 Body fat percentage
4 WC
Parnell and Reimer DB, parallel arm Oligofructose powder in Maltodextrin powder in 21 g/d Not reported 12 9 20–70 y old 39 Y Weight
2009 (224) participant-selected participant-selected BMI .25 Treatment: 21
THOMPSON ET AL.

beverages beverages Placebo: 18


Reimer et al., 2013 DB, parallel arm Glucomannan, alginate, and Rice flour powder in 15 g/d Treatment: 9.6 14 8 Asian adults aged 20–65 y 56 4 Weight
(225) xanthan gum powder in yogurt Placebo: 9.6 BMI: 24–30 Treatment: 28 4 BMI
yogurt Placebo: 28 Y WC
Y Glucose
4 Insulin
Salinardi et al., DB, parallel arm Manno-oligosaccharide Coffee beverage without 4 g/d Not reported 12 9 19–65 y old 54 4 Weight
2010 (226) powder in coffee beverage fiber BMI: 27–33 Treatment: 29
Placebo: 25
Savastano et al., DB, parallel arm Pectin and oligofructose Maltodextrin powder in HD: 30 g/d HD treatment: 17.1 3 10 18–60 y old 88 4 Weight
2014 (43) powder in water water LD: 15 g/d LD treatment: 16.9 BMI: 25–34.9 Treatment: 30 HD, 4 Glucose
Placebo: 16.3 29 LD
Placebo: 29 4 Insulin
4 HOMA-IR
Vulevic et al., DB, crossover Galacto-oligosaccharide Maltodextrin powder in 5.5 g/d Not reported 12 9 18–65 y old 45 4 Glucose
2013 (227) powder in water water BMI .25 Treatment: 45 Y Insulin
Placebo: 45
Walsh et al., 1984 DB, parallel arm Glucomannan powder in Starch powder in capsules 3 g/d Not reported 8 7 Obese women at .20% 20 Y Weight
(217) capsules of ideal body weight Treatment: 10
Placebo: 10
1
Arrows indicate the direction of outcomes that were evaluated by the authors within the primary studies after soluble fiber consumption (4, null; Y, significant decrease). Glucose and insulin values refer
to fasting concentrations. DB, double blinded; HD, high dose; LD, low dose; MQS, Heyland Methodologic Quality Score; RCT, randomized controlled trial; ref, reference; SB, single blinded; WC, waist
circumference.

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SUPPLEMENTAL FIBER IMPROVES WEIGHT AND GLYCEMIA 1519
TABLE 2
Risk of bias for studies included in the meta-analysis according to the Cochrane Risk of Bias Tool1
Random- Participant- Outcome- Incomplete
sequence Allocation personnel assessment outcome Selective
Study, year (ref) generation concealment blinding blinding data reporting Other bias

Bays et al., 2011 (42) Unclear Unclear Low Low Low Low Low
Brahe et al., 2015 (219) Low Low High Unclear Low Low Low
Genta et al., 2009 (220) Unclear Unclear Low Low High Low Low
Kobayakawa et al., 2013 (221) Low Low Low Low Low Low Low
Li et al., 2010 (222) Low Low Low Low Low Low Low
Morel et al., 2015 (223) Low Unclear Low Low Low Low Low
Parnell and Reimer, 2009 (224) Low Unclear Low Unclear Low Low Low
Reimer et al., 2013 (225) Unclear Unclear Low Low Low Low Low
Salinardi et al., 2010 (226) Low Low Low Low Low Low Low
Savastano et al., 2014 (43) Low Low Low Low Low Low Low
Vulevic et al., 2013 (227) Unclear Unclear Low Low Low Low Low
Walsh et al., 1984 (217) High Unclear Low Low Unclear Unclear Low
1
Bias designations by study criteria are indicated by 7 domains with categories including low risk if negative aspects of the study design were not likely
to influence the study findings, high risk if the study design was likely to influence the study findings, or unclear risk if high or low risk could not be assigned
because of a lack of evidence. Ref, reference.

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concealed randomization procedures (219, 221), and 3 studies fiber consumption on waist circumference (22.01 cm; 95% CI:
used intention-to-treat statistical procedures (43, 222, 223). Two- 25.36, 1.35 cm; I2 = 97%). In a sensitivity analysis, the removal
thirds of studies described treatment and control groups as being of Genta et al. (220) from the meta-analysis substantially re-
similar at the baseline time point (42, 217, 220, 221, 223, 224, 226, duced I2 measures of between-study heterogeneity to 77% for
227). A total of 87% of studies used double-blinded RCT designs BMI, to 76% for body weight and the percentage of body fat
(42, 43, 217, 220–227), and nearly all (93%) of the studies (Supplemental Figure 2), and to 15% for waist circumference,
provided a detailed description of study procedures (42, 43, 219, but significant differences between soluble fiber treatment and
221–227). A majority of trials (n = 10) were considered to have low placebo treatment remained for these outcomes. A sensitivity
risk of bias according to the Cochrane Risk of Bias Tool (Sup- analysis also revealed that the significant differences that were
plemental Figure 1, Table 2). observed between placebo and soluble fiber treatment on BMI,
body weight, and the percentage of body fat persisted after the
removal of other potential outlier studies that shifted the pooled
Meta-analysis on body composition mean difference $10%. The percentage of mean difference
change was .10% in 5 of 7 studies for BMI (219, 220, 222, 223,
Body-composition meta-analyses are presented in Table 3 and
225), in 4 of 10 studies for body weight (219, 220, 225, 226), in
Figure 2 for BMI (n = 7 studies) (219–225), body weight (n =
3 of 4 studies for the percentage of body fat (219, 223, 224), and
10) (43, 217, 219–226), percentage of body fat (n = 4) (219,
in 4 of 6 studies for waist circumference (219, 220, 222, 223).
222–224), and waist circumference (n = 6) (219–223, 225).
Soluble fiber supplementation reduced BMI by 0.84 (95% CI:
21.35, 20.32; I2 = 95%, P = 0.001), body weight by 2.52 kg
(95% CI: 24.25, 20.79 kg; I2 = 96%, P = 0.004), and per- Meta-analysis on fasting glucose, insulin, and HOMA-IR
centage of body fat by 0.41% (95% CI: 20.58%, 20.24%; Meta-analysis results for fasting glucose (n = 8 studies) (42, 43,
I2 = 89%) (P = 0.000) compared with the effects of the placebo 219–221, 224, 225, 227), fasting insulin (n = 7) (42, 219–221, 224,
treatment. There was no significant effect (P = 0.24) of soluble 225, 227), and HOMA-IR (n = 5) (42, 219–221, 225) are shown in

TABLE 3
Meta-analysis and publication bias results for included studies1
P

Outcome Included studies, n (references) Pooled difference2 P Egger’s test Begg’s test

BMI, kg/m 2
7 (219–225) 20.84 (21.35, 20.32) 0.001 0.62 0.65
Body weight, kg 10 (43, 217, 219–226) 22.52 (24.25, 20.79) 0.004 0.28 0.42
Body fat, % 4 (219, 222–224) 20.41 (20.58, 20.24) ,0.00001 0.95 1.00
Waist circumference, cm 6 (219–223, 225) 22.01 (25.36, 1.35) 0.24 0.69 0.85
Glucose, mmol/L 8 (42, 43, 219–221, 224, 225, 227) 20.17 (20.28, 20.06) 0.002 0.87 1.00
Insulin, pmol/L 7 (42, 219–221 224, 225, 227) 215.88 (229.05, 22.71) 0.02 0.11 0.88
HOMA-IR 5 (42, 219–221, 225) 21.33 (22.98, 0.32) 0.12 0.54 1.00
1
Meta-analysis was conducted with the use of random-effects models. Publication bias was assessed with the use of Egger’s and Begg’s tests.
2
All values are between-group means (95% CIs) between soluble fiber–treatment and placebo groups.
1520 THOMPSON ET AL.

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FIGURE 2 Forest plots for randomized controlled trials of soluble fiber–intervention studies included in a BMI (in kg/m2) subgroup meta-analysis (n = 358) (A),
a body weight subgroup meta-analysis (expressed as kg) (n = 520), body fat subgroup meta-analysis (expressed as %) (n = 237) (C), and waist-circumference subgroup
meta-analysis (expressed as cm) (n = 320) (D). Random-effects models were used to calculate mean differences (gray squares), 95% CIs (horizontal lines through gray
squares), and pooled-effect sizes (black diamonds). The study weight (expressed as %) indicates the relative contribution of individual studies to the overall pooled-
effect size. Between-study heterogeneity was calculated via the I2 statistic.
SUPPLEMENTAL FIBER IMPROVES WEIGHT AND GLYCEMIA 1521

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FIGURE 3 Forest plots for soluble fiber–intervention studies included in meta-analyses for a fasting glucose subgroup meta-analysis (expressed as mmol/L)
(n = 415) (A), fasting insulin subgroup meta-analysis (expressed as pmol/L) (n = 327) (B), and HOMA-IR subgroup meta-analysis ( n = 200) (C). Random-effects
models were used to calculate mean differences (gray squares), 95% CIs (horizontal lines through gray squares), and pooled-effect sizes (black diamonds). The study
weight (expressed as %) indicates the relative contribution of individual studies to the overall pooled-effect size. Between-study heterogeneity was calculated via the I2
statistic.

Table 3 and Figure 3. Soluble fiber supplementation reduced Publication bias assessment
fasting glucose concentrations by 0.17 mmol/L (95% CI: 20.28, No publication bias was indicated for any outcomes as de-
20.06 mmol/L; I2 = 56%, P = 0.002) and fasting insulin con- termined via a funnel plot inspection and Begg’s test and Egger’s
centrations by 15.88 pmol/L (95% CI: 229.05, 22.71 pmol/L; test P values .0.05 (Table 2).
I2 = 88%, P = 0.02) compared with the effects of the placebo.
The numeric reduction in HOMA-IR of 1.33 U with soluble fiber
supplementation was NS (95% CI: 22.98, 0.32 U; I2 = 97%, P = Meta-regressions for intervention duration, fiber dose, and
0.12). The omission of Genta et al. (220) from the meta-analysis fiber type
reduced I2 measures of between-study heterogeneity to ,50% The intervention duration (range: 2–17 wk) and fiber dose
for fasting glucose, fasting insulin, and HOMA-IR (Supplemental (range: 3–34 g/d) were not significantly related to study out-
Figure 3) while maintaining the significant differences between comes. Meta-regressions that were conducted by fiber type
soluble fiber treatment and the placebo. The percentage of mean indicated a more pronounced reduction in HOMA-IR (re-
difference change was.10% in 3 of 8 studies for fasting glucose gression coefficient: 24.11; P = 0.009; 95% CI: 25.77, 22.46)
(219, 221, 224), in 2 of 7 studies for fasting insulin (220, 224), and by nonviscous, fermentable, soluble fiber supplements than by
in 4 of 5 studies for HOMA-IR (219–221, 225). viscous, fermentable fiber types.
1522 THOMPSON ET AL.

DISCUSSION (SMD: 20.77; 95% CI: 21.50, 20.04) but a nonsignificant


This systematic review and meta-analysis of RCTs revealed change in body weight (SMD: 20.48; 95% CI: 21.19, 0.23)
significant reductions in BMI, body weight, body fat, and (231).
fasting glucose and insulin concentrations after soluble fiber Limitations of the present study should be noted. The number
supplementation in overweight and obese adults without of eligible studies was small, and no soluble fiber or placebo
physician-diagnosed disease. A meta-analysis of body- treatment was provided twice. A sensitivity analysis also revealed
composition measures revealed significant, clinically mean- the presence of influential outlier studies. One study (220) in-
ingful reductions of 0.84 U BMI and 2.5 kg body weight when creased the heterogeneity across outcomes; however, its removal
isolated soluble fiber was compared with placebo. Even slight did not negate detected differences between soluble fiber and
reductions in weight can produce metabolic improvements. Each placebo groups. The outcome’s significance was unaffected by
kilogram of lost body weight was connected with a 16% re- this study’s omission, but the heterogeneity remained high for
duction in type 2 diabetes risk (228), and a 2–5% weight loss was BMI and body weight. We evaluated the efficacy of isolated
linked to improvements in fasting blood glucose and glycated soluble fiber on body composition and metabolic outcomes
hemoglobin, which are 2 recognized cardiovascular disease risk independent of researcher-imposed energy restriction or
factors (229). weight-loss counseling. Despite weight-maintenance protocols,
Meta-regressions revealed differences in HOMA-IR by fiber 3 studies reported reduced energy intake in treatment groups
type with a more pronounced reduction in insulin resistance (222–224), thus providing evidence that may support the sati-
observed with nonviscous, fermentable fiber. Previous research ating impact of soluble fiber. Fiber-related satiation and other
has indicated variable physiologic effects for soluble fibers mechanisms of action could not be assessed in the present study
nor could the long-term impact of soluble fiber supplementation

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with different viscosity and fermentability profiles (26, 35,
170). Soluble, viscous, fermentable fiber is known to lower beyond the published study-treatment period. Our findings may
blood glucose and lipid concentrations (26, 230), and emerging not be generalizable to healthy-weight individuals or patients
research has indicated that similar metabolic improvements with diagnosed chronic conditions although a review of studies
may result from nonviscous, fermentable fiber consumption that were conducted in type 2 diabetes patients reported a 50%
(231). Meta-regressions of fiber doses (3–34 g) and inter- reduction in the postprandial glucose peak after soluble fiber
vention durations (2–17 wk) revealed that these factors were intake that was equivalent to 8–10% of the total cereal gram
not associated with investigated outcomes. Weight loss oc- weight (233). There are several methodologic strengths of the
curred after a 3-mo supplementation period with the use of 3 g present study. Our analysis involved high-quality studies (mean
glucomannan/d and 34 g soluble dextrin/d (217, 222). These MQS: 8.9) and rigorous exclusion criteria that reduced the
findings may be related to differences in polymer chain length presence of confounding variables such as a diagnosed disease
and fermentability between fiber types with the potentially and weight-loss counseling. A thorough assessment of study
more fermentable glucomannan having a stronger impact per quality and biases was performed with the use of validated
gram on anthropometric or metabolic outcomes than would methods, and we investigated sources of study heterogeneity
using a sensitivity analysis.
soluble dextrin (232). It is also reasonable to postulate that the
In conclusion, because of the observed improvements in
lack of dose response could indicate benefits for even slight
body composition, glucose, and insulin in the present study and
increases in soluble fiber consumption.
the extensive dietary fiber intake gap between recommended
To our knowledge, this meta-analysis is the first to assess the
intake and actual dietary fiber intake in the United States,
efficacy of isolated soluble fiber supplementation within RCTs on
isolated soluble fiber supplementation may be a feasible ap-
body composition and metabolic health in overweight and obese
proach to improve weight and metabolic health in overweight
adults. Existing systematic reviews and meta-analyses have
and obese individuals. Indeed, the findings reported herein
mostly focused on individual soluble fiber types or pooled studies
provide evidence that enhancing the fiber content of the food
with varied study designs and participant populations (e.g.,
supply via isolated soluble fiber supplementation may benefit
healthy adults assessed alongside individuals with diagnosed
this at-risk population, which has important implications to
chronic disease). In accordance with our findings, one review of
food regulators, manufacturers, clinicians, and consumers
insoluble and soluble fiber interventions (177) reported a mean
alike. Although caution is warranted when evaluating our
weight loss of 1.9 kg over 3.8 mo with 14 g additional dietary
findings because of the high between-study heterogeneity,
fiber/d, and a glucomannan-focused meta-analysis observed re-
these results suggest that isolated soluble fiber supplementation
ductions in fasting glucose by 0.44 mmol/L (95% CI: 214.16,
has promising implications for weight management and im-
20.72 mmol/L) and in body weight by 0.79 kg (95% CI: 21.53,
proved glucose and insulin homeostasis in overweight and
20.05 kg) (197). Another systematic review showed that iso-
obese individuals.
lated soluble fiber decreased energy intake (69% compared with
30%) and appetite (59% compared with 14%) more frequently We thank Caitlyn Edwards for her contributions, George Fahey for review-
than did insoluble fiber treatments (29). However, unlike our ing the manuscript, and Nicola McKeown for the helpful dietary fiber research
study, significant reductions in body-composition outcomes study database.
The authors’ responsibilities were as follows—SVT and BAH: conducted
were not observed between isolated soluble fiber and insoluble
the research; SVT: performed the statistical analysis; HDH: had primary
fiber (29). Another meta-analysis that was specific to soluble, responsibility for the final content of the manuscript; and all authors: con-
fermentable, and nonviscous fiber treatments reported a signif- tributed to the research design, wrote the manuscript, and read and approved
icant lowering of postprandial glucose [standardized mean dif- the final manuscript. None of the authors reported a conflict of interest re-
ference (SMD): 20.76; 95% CI: 21.41, 20.12) and insulin lated to the study.
SUPPLEMENTAL FIBER IMPROVES WEIGHT AND GLYCEMIA 1523
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