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ABSTRACT glycemic control (5) or an effect only when psyllium was sprin-
Background: Water-soluble dietary fibers decrease postprandial kled onto or incorporated into a cereal meal (6).
glucose concentrations and decrease serum cholesterol concen- Psyllium has been shown to significantly reduce postprandial
trations. This study examined the effects of administering psyl- serum glucose and insulin concentrations in nondiabetic individ-
lium to men with type 2 diabetes. uals (7). Numerous studies of nondiabetic individuals indicate
Objective: The objective was to evaluate the safety and effec- that psyllium significantly lowers both total and LDL-cholesterol
INTRODUCTION
Psyllium husk fiber is a viscous, mostly water-soluble fiber 1
From the Veterans Affairs Medical Center, the University of Kentucky,
prepared by mechanical removal of the husk from blonde psyl-
Lexington, and The Procter & Gamble Company, Cincinnati.
lium seed (Plantago ovata). Early or uncontrolled studies sug- 2
Supported by The Procter & Gamble Co, Cincinnati.
gested that psyllium improved glycemic and lipid control in 3
Address reprint requests to JW Anderson, Veterans Affairs Medical Cen-
individuals with type 2 diabetes (13). Although a more recent ter, Medical Services (111C), 2250 Leestown Road, Lexington, KY 40511. E-
and carefully controlled study reported reduced postprandial mail: Jwandersmd@aol.com.
glucose and insulin concentrations with psyllium supplementa- Received April 21, 1998.
tion in type 2 diabetes (4), other studies found no effect on Accepted for publication December 21, 1998.
466 Am J Clin Nutr 1999;70:46673. Printed in USA. 1999 American Society for Clinical Nutrition
GLYCEMIC AND LIPID RESPONSES TO PSYLLIUM 467
University of Kentucky reviewed and approved the study and During the metabolic ward evaluations, subjects received
informed consent was obtained from each subject. standardized meals low in fiber to enhance detection of the
Individuals were eligible for the study if they were men aged effects of fiber on glucose and lipid metabolism, as described
3070 y; had a body mass index (in kg/m2) of 30; had a his- previously (8). Subjects consumed a low-fat, low-fiber meal
tory of stable type 2 diabetes meeting the criteria of the (65% of energy as carbohydrate, 15% as protein, 20% as fat, and
National Diabetes Data Group (17), with a fasting blood glu- 50 mg cholesterol/MJ) on the evening of the first day of the
cose concentration of 8.3311.10 mmol/L and a serum glycated metabolic ward evaluation. On day 2 of the metabolic-ward eval-
hemoglobin (Hb A1c) concentration of 9% (mean of values uation, subjects consumed 3 meals providing 40% of energy as
taken in weeks 22 and 21 of the study); and had mild-to-mod- carbohydrate, 15% as protein, 45% as fat, 50 mg cholesterol/MJ,
erate hypercholesterolemia, with a stable serum total choles- and 0.8 g dietary fiber/kJ.
terol concentration of 5.177.76 mmol/L and triacylglycerol
concentration of 5.65 mmol/L (mean of weeks 22 and 21). Measurements
Individuals whose diabetes was controlled with diet only or diet Dietary compliance throughout the study was monitored by
plus oral sulfonylurea agents were eligible for study. Individuals using 3-d food records collected at weeks 21, 4, and 8. Dietary
were excluded from the study if they had medical conditions or data were analyzed for energy, total fat, polyunsaturated fat,
were taking medications or supplements that might have inter- saturated fat, carbohydrate, protein, total fiber, soluble fiber,
fered with glucose, insulin, or lipid measurements. Individuals and cholesterol contents by using a computerized nutrient data-
with a history of myocardial infarction or major surgical proce- base (18) with revised fiber values (19). Compliance with test
dures within the previous 6 mo were excluded from the study, as product use was monitored by subject interviews and by count-
were individuals with a history of alcohol abuse, allergy to ing unopened packets at follow-up visits. Reports of any treat-
aspartame or psyllium seed, or phenylketonuria. ment-related adverse experience were solicited at each follow-up
TABLE 2
Daily nutrient intakes of subjects in the psyllium and control groups1
Control Psyllium
(n = 14) (n = 15)
Nutrient Baseline Final Baseline Final
Energy (MJ) 4.62 0.40 4.71 0.40 5.88 0.32 2
5.39 0.26
Carbohydrate (% of energy) 43.8 1.8 48.5 1.7 48.2 2.3 48.3 2.3
Protein (% of energy) 22.6 1.7 22.6 0.9 20.2 0.9 20.2 1.1
Total fat (% of energy) 33.6 1.5 28.8 1.4 31.4 2.1 31.2 1.7
Saturated fat (% of total fat) 35.1 1.2 32.7 1.4 34.4 1.6 32.0 2.1
P:S3 0.61 0.08 0.68 0.09 0.69 0.09 0.65 0.10
Cholesterol (mg) 262.1 36.4 194.9 33.4 269.2 39.5 280.3 35.8
Total fiber (g) 11.4 1.7 13.7 1.7 17.0 2.2 15.1 1.9
Soluble fiber (g) 4.2 0.6 4.7 0.6 5.3 0.6 4.9 0.7
1
x SEM. Baseline and final values were measured at weeks 21 and 8, respectively.
2
Significantly different from control group, P < 0.05.
3
Ratio of polyunsaturated to saturated fat.
All subjects maintained their body weights within 5% dur- sion, baseline serum glucose values averaged 7.6 0.6 and
ing the study. As shown in Table 3, body weight decreased 0.3% 7.5 0.5 mmol/L in the psyllium and placebo groups, respec-
TABLE 3
Serum glycemic and lipid responses in metabolic ward and outpatient settings in subjects in the psyllium and control groups1
Control (n = 14) Psyllium (n = 15)
Baseline Percentage change Baseline Percentage change
Outpatient
Body weight (kg) 87.1 3.3 1.5 0.7 89.6 2.4 20.3 0.42
Glucose (mmol/L) 10.74 0.56 2.8 4.6 10.02 0.41 26.1 4.5
Hb A1C 0.075 0.002 20.8 4.3 0.073 0.003 26.3 3.1
Glycated albumin 0.0222 0.0010 25.6 6.2 0.020 0.001 23.1 4.1
Total cholesterol (mmol/L) 5.89 0.15 2.8 2.3 6.08 0.18 22.3 2.2
LDL cholesterol (mmol/L) 3.80 0.17 2.8 3.4 4.00 0.23 24.9 2.4
HDL cholesterol (mmol/L) 0.94 0.05 8.8 2.3 0.97 0.07 20.9 3.02
Triacylglycerols (mmol/L) 2.50 0.20 20.4 5.3 2.71 0.35 27.0 13.3
Metabolic ward
Glucose (mmol/L)
Postbreakfast 13.54 0.95 3.8 4.7 13.44 0.82 23.0 4.6
Postlunch 10.43 0.83 12.7 5.6 10.75 0.69 26.5 4.23
Postdinner 10.89 0.61 2.2 3.9 11.80 0.75 25.7 4.5
All day 11.53 0.76 6.8 3.9 11.90 0.70 24.2 3.32
Total cholesterol (mmol/L) 5.39 0.17 6.9 2.4 5.69 0.20 22.1 2.32
LDL cholesterol (mmol/L) 3.39 0.17 8.3 5.3 3.81 0.19 24.7 4.3
0.85 0.05 2.0 2.2 0.88 0.07 0.6 3.1
clinically significant changes occurred in clinical chemistry, psyllium treatment (5.1 g twice daily) in subjects consuming a
hematology, or urinalysis indexes as a result of treatment in low-fat diet. In a similar study with an 8-wk dietary stabilization
either group. Although the difference in changes from baseline phase, Bell et al (12) reported significant net decreases in total
between the psyllium and placebo groups was significant for and LDL-cholesterol concentrations of 4.8% and 8.2%, respec-
total protein, g-glutamyltransferase concentrations, and some tively, after psyllium and placebo supplementation.
leukocyte indexes, none of these indexes changed significantly In large-scale studies of nondiabetic individuals with hyper-
from baseline in the psyllium group. cholesterolemia, 816 wk of psyllium treatment after a dietary
stabilization phase reduced serum total cholesterol concentra-
tions by 3.55.6% and serum LDL-cholesterol concentrations
DISCUSSION by 5.18.8% compared with placebo treatment (8, 1012). This
This study was designed to evaluate the safety and effective- smaller-scale study may not have had sufficient statistical power
ness of psyllium compared with a cellulose placebo used adjunc- to detect all significant treatment effects of psyllium. Additional
tively to a traditional diabetes diet in men with type 2 diabetes larger-scale studies are needed to confirm the preliminary
and mild-to-moderate hypercholesterolemia. Significant differ- results of this study.
ences in changes from baseline between treatment groups were Earlier studies reported that psyllium reduced fasting serum
seen in both glycemic and lipid indexes evaluated in the meta- glucose concentrations (1) or decreased postprandial serum glu-
bolic ward, with the psyllium group showing improved meta- cose concentrations (30) in individuals with type 2 diabetes. In
bolic control compared with the placebo group. Although most another study, psyllium reduced the glycemic response of dia-
changes in glycemic and lipid indexes during the outpatient eval- betic individuals to a flaked bran cereal test meal only when
uations were not significantly different between treatment psyllium was incorporated into or sprinkled onto the cereal (6).
groups, directional changes also suggested improved metabolic In a carefully controlled crossover study of the effects of psyl-
control in the psyllium group. lium taken immediately before breakfast and dinner compared
The magnitude of serum total and LDL-cholesterol reductions with the effects of cellulose placebo supplementation in individ-
seen in this study were similar to reductions reported in studies of uals with type 2 diabetes, postprandial serum glucose values
nondiabetic individuals. Sprecher et al (10) reported significant were 14% lower after breakfast, 31% lower after lunch, and 20%
net decreases (psyllium minus placebo) in total and LDL choles- lower after dinner with psyllium (4). The ability of soluble fibers
terol-concentrations of 3.5% and 5.1%, respectively, after 8 wk of to reduce the postprandial glucose response to meals eaten
GLYCEMIC AND LIPID RESPONSES TO PSYLLIUM 471
several hours after fiber ingestion (eg, the so-called second meal dietary instruction and monitoring in this study was to ensure that
effect) was shown previously in nondiabetic individuals (31, 32). dietary intake did not change significantly and that there were no
The second-meal effect of psyllium was also evident in the significant differences in dietary intake between treatment groups
present study. Two doses of psyllium taken immediately before during the study. Careful dietary studies require intensive instruc-
breakfast and dinner resulted in significantly lower metabolic tion and monitoring beyond the scope of this study.
ward measurements of all-day postprandial glucose and postlunch Psyllium is a viscous water-soluble fiber that has long been
serum glucose concentrations in the psyllium than in the placebo used as a bulk laxative with a good safety record. Although the
group. All-day and postlunch postprandial glucose concentrations role of dietary fiber in nutrition therapy for type 2 diabetes
were 11.0% and 19.2% lower, respectively, in the psyllium than in remains controversial (34, 35), several studies indicate that high-
the placebo group. fiber diets (3640) or diets supplemented with soluble fibers such
It is unlikely that the steady improvements in metabolic as guar gum (41), soy (42), or pectin (43) improve metabolic con-
indexes seen in the psyllium group in this study were due to trol in many individuals with type 2 diabetes. The practical appli-
weight changes. Although body weights were 1.8% lower in the cations for some soluble fiber sources, however, are limited
psyllium group than in the placebo group at week 8 (P < 0.05), because of the lack of palatable forms. In this study, psyllium was
no consistent trends in body weight were seen during this study. well tolerated, was associated with no serious adverse events, and
Except for higher energy intakes in the psyllium group at base- improved metabolic control compared with a cellulose placebo.
line, dietary intakes were not significantly different between groups Medical nutrition therapy in type 2 diabetes must be individu-
during the study. The low energy intakes reported by both groups alized to reflect personal lifestyle and management goals (44).
indicated that subjects underreported their food intakes, as was Because type 2 diabetes markedly increases the risk of atheroscle-
documented in other clinical studies (33). The present study was rosis and its complications (45), achievement and maintenance of
not intended to be a careful dietary study but, rather, the purpose of normal serum lipid concentrations is a primary goal of diabetes
472 ANDERSON ET AL
management that could greatly reduce death and disability in this 17. National Diabetes Data Group. Classification and diagnosis of dia-
population. Results of this study suggest that the addition of psyl- betes mellitus and other categories of glucose intolerance. Diabetes
lium to a standard diet for diabetes is safe, is well tolerated, and 1979;28:103957.
18. North S, North L. Nutritionist III. Silverton, OR: N-Squared Com-
offers an additional dietary tool to improve metabolic control in
puting, 1988.
individuals with type 2 diabetes and hypercholesterolemia.
19. Anderson JW. Plant fiber in foods. Lexington, KY: HCF Nutrition
Research Foundation, 1990.
We acknowledge the expert technical writing skills of Nancy J Gustafson
20. DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a
and the statistical expertise of Heather A Tully.
method for quantifying insulin secretion and resistance. Am J Phys-
iol 1979;237:E21423.
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