Name of Students: Daquipil, Micah Perry P., Duque, Jeswon M.

, Date Submitted:___________
Evasco, Keziah Hannah P., Fabricante, Date Returned:___________
Princess Keren P., Hadji Omar, Janal T.,
Madelo, Dannielle Paige S., Pendatun,
Omar Khalif A., Tampogao, Norjanah M.,
Tangkusan, Farr Krizha I., Tolentino, Jean S.

___ Approved/For Revisions ___Disapproved

TITLE OF STUDY: “A RANDOMIZED PLACEBO-CONTROLLED STUDY ON THE

LOWERING EFFECTS OF ORANGE (Citrus reticulata) PEEL
INFUSION ON THE TOTAL SERUM CHOLESTEROL LEVEL OF
ADULT MALE INDIVIDUALS IN ILIGAN CITY”

BACKGROUND/SIGNIFICANCE OF THE STUDY:

The use of herbal medicine has always been part of human culture, as some plants possess
important therapeutic properties which can be used to manage certain diseases. The use of herbal
plants as managements to different diseases is gaining popularity in the current generation. Its
popularity is further increased by its affordability, less side effects and toxicity than those
commercialized ones. The affordability is most beneficial to those from low socioeconomic class.
Orange (Citrus reticulata) or most commonly known in the Philippines as ponkan, is a citrus fruit
found in tropical to semitropical, evergreen, small flowering trees. It is well established that some
of the nutrients in citrus promote health and provide protection against chronic diseases. More
recently, the role of bioactive non-nutrient component called phytochemicals has received
increasing attention. One of the different classes of phytochemicals is the flavonoids and flavones
are one of the sub-groups under flavonoids. Polymethoxylated flavones (PMFs) are found
especially in large amounts in the peel of citrus fruits. According to different studies such as that
by Evans, et al, (2014) tangeretin and nobiletin which are PMFs are present in orange peel and has
demonstrated efficacy in decreasing total serum cholesterol. The study will be undertaken with the
hope that this could ascertain the beneficial role of orange peel in lowering the serum cholesterol
levels of adult male individuals.

STATEMENT OF THE PROBLEM:

Is there a significant difference between the total serum cholesterol level of the control group
receiving the placebo and the treatment group receiving the orange peel tea?

HYPOTHESIS:
H0: There is no significant difference between the total serum cholesterol levels of the control
group receiving placebo and the treatment group receiving the orange peel tea.

H1: There is significant difference between the total serum cholesterol levels of the control
group receiving placebo and the treatment group receiving the orange peel tea.
OBJECTIVES:
This study aims to determine if there is any significant difference between the serum total
cholesterol levels of the control group receiving the placebo and the treatment group receiving the
orange peels as tea. Specifically, it aims to determine: (1) the mean percentage difference of the
preliminary test and posttest value of the serum cholesterol levels of the placebo group; (2) the
mean percentage difference of the preliminary test and posttest value of the serum cholesterol
levels of the treatment group; (3) if there is a significant difference in the mean percentage
difference of the pretest and posttest results of the serum cholesterol levels between the placebo
and the treatment group.

METHODOLOGY:
A simple randomized sampling, placebo-controlled clinical trial study will be conducted
in Iligan City within a six-week period. A total of sixty (60) individuals will be chosen, thirty (30)
for the placebo group and another thirty (30) for the treatment group. The following inclusion
criteria were considered for selecting the respondents for this study: (1) male, at least 18 years old
up to 45 years old; (2) individuals with no existing cardiovascular diseases and its risk equivalents
(DM, peripheral artery disease, cerebrovascular disease, etc.); (3) individuals with a serum total
cholesterol level between 160 mg/dL – 200 mg/dL. Hereinafter, these are the criteria for excluding
individuals not qualified for the study: (1) individuals taking medications that can alter cholesterol
absorption (e.g. antihyperlipidemic medications, nutritional supplements and any other
maintenance medications); (2) individuals with known food and drug allergies; (3) individuals
with concurrent GI disturbances; and (4) individuals with kidney disease.

C. reticulata will be obtained from a supplier in Iligan City. The fruits will be washed and
the peels isolated. The peels will then be air-dried for 48hrs. After drying, the peels will be coarsely
chopped and then packaged in tea bags with 15g of coarsely chopped peels each. The placebo, on
the other hand, will be prepared based on the color and taste of the peel infusion. Six liters of
distilled water will be mixed with two tablespoons of McCormick orange flavoring. Brown food
coloring will also be added imitate the natural color of the infusion.

For operational definition of terms, orange peel is the rind of an orange separated from the
pulp that will be air-dried and chopped to be utilized as tea; infusion refers to the process of pouring
boiled water into cup with a tea bag; placebo is a stimulated treatment administered to control an
experiment and does not contain the active ingredient.

To determine if there is a significant difference between the placebo and treatment groups,
the researchers will use an independent T-test.

DUMMY TABLES:
Table 1. Pretest and Posttest Cholesterol Values of Placebo Group
Cholesterol Measurement
Placebo Age Sex Lifestyle Percent change
Pre-test Posttest
Table 2. Pretest and Posttest Cholesterol Values of Treatment Group
Cholesterol Measurement
Treatment Age Sex Lifestyle Percent change
Pre-test Posttest

BIBLIOGRAPHY:

Adams, C., & Naturopath. (2011). Orange peels reduce LDL cholesterol - heal naturally.
Retrieved September 13, 2016, from Health, http://www.realnatural.org/orange-peels-reduce-ldl-
cholesterol/

Baghurst, K. (2003). The Health Benefits of Citrus Fruits. Sydney: Horticulture Australia.

Li, R., Theriault, A., Au, K., Douglas, T., Casaschi, A., et al (2006). Citrus polymethoxylated
flavones improve lipid and glucose homeostasis and modulate adipocytokines in fructose-
induced insulin resistant hamsters. Life sciences., 79(4), 365–73. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/16497336