Effect of Bitter Melon Seed Oil on Body Weight
Primary Purpose
Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BMSO
OO
Sponsored by
About this trial
This is an interventional prevention trial for Weight Gain focused on measuring Bitter melon seed oil, Olive oil, Weight control, UCP1 polymorphism
Eligibility Criteria
Inclusion Criteria:
- adults with overweight or obesity (BMI ≥ 24 kg/m2 or waist circumference > 90 cm in males and > 80 cm in females)
- 20-64 y of age
- not currently using any weight-reducing agent
Exclusion Criteria:
- diabetes
- endocrine disease
- uncontrolled high blood pressure (systolic ≥ 180 mm Hg or diastolic ≥ 110 mm Hg)
- liver, kidney, or cardiovascular disease
- gastrointestinal disease
- psychological diseases
- pregnancy or lactation
- asthma and allergies
- smoking
- use of any drugs or dietary supplements that potentially affected body weight, blood lipids, blood pressure, or inflammatory responses.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMSO
OO
Arm Description
Bitter melon seed oil supplementation
Olive oil supplementation
Outcomes
Primary Outcome Measures
Weight gain
Changes at intervention for 4,8 and 12 week
Secondary Outcome Measures
BMI
Changes at intervention for 4,8 and 12 week
waist-to hip ratio
Changes at intervention for 4,8 and 12 week
body fat mass
Changes at intervention for 4,8 and 12 week
Full Information
NCT ID
NCT03785821
First Posted
December 13, 2018
Last Updated
December 20, 2018
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03785821
Brief Title
Effect of Bitter Melon Seed Oil on Body Weight
Official Title
Development and Clinical Application of Bitter Melon Seed Oil as a Functional Food for Treating Obesity and Hepatic Steatosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the metabolic benefits of bitter melon seed oil (BMSO), overweight or obese healthy Taiwanese adults (n=60) were randomly assigned to receive capsules containing either olive oil (OO; placebo) or BMSO at 4.5 g/d dose for 12 week. Across intervention period, body weight, BMI, waist-to-hip ratio, and body fat mass were measured. Blood were collected before and after intervention for measurements of blood lipid and inflammatory cytokines. The anti-obesity effect of BMSO was further assessed by stratification of participants according to UCP1 rs1800592 polymorphism.
Detailed Description
Bitter melon is a common Asian vegetable. Its seed is not edible and discarded as a waste product. However, the seed oil is enriched in cis9, trans11, trans13-conjugated linolenic acid or alpha-eleostearic acid (alpha-ESA). Investigators previously demonstrated the anti-obesity functions of bitter melon seed oil (BMSO) in animal trials. Herein, a RCT was conducted to test the potential of BMSO in developing as a functional culinary oil for weight control.
Considering UCP-1 played a pivotal role in anti-adiposity function of BMSO as demonstrated in animal studies, the anti-obesity effect of BMSO was further assessed according to UCP1 rs1800592 polymorphism.
Healthy Taiwanese adults with overweight or obesity were recruited by advertisement and were assessed by a family medicine physician for eligibility. All participants signed the consent form. Blocked randomization was used to randomly assign participants into one of two groups to receive indicated supplement (BMSO or OO capsules with identical appearance; 4.5 g oil/d) for 12 week. Subjects were requested to maintain their usual diet and physical activity during the study period (0-12 week).
Anthropometric measurements were done on week 0, 4, 8 and 12. Three-day food records, collection of blood samples and physical health check were conducted on week 0, 4 and 12. Indirect calorimetry was done on week 0 and 12. Questionnaires about self-reported side effects, such as trouble sleeping, constipation, diarrhea, increased heartbeat, palpitations, headache, anxiety, or dizziness, were collected in each visit. Group allocation was concealed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
Bitter melon seed oil, Olive oil, Weight control, UCP1 polymorphism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMSO
Arm Type
Experimental
Arm Description
Bitter melon seed oil supplementation
Arm Title
OO
Arm Type
Placebo Comparator
Arm Description
Olive oil supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
BMSO
Intervention Description
BMSO was extracted from Hualien No. 4 cultivate of bitter melon seed. BMSO were incorporated into capsules containing 0.5 g of oil. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily, resulting in daily consumption of 2.3 g alpha-ESA in the BMSO group.
Intervention Type
Dietary Supplement
Intervention Name(s)
OO
Intervention Description
Olive oil (extra virgin grade) was purchased from La Espanola (Acesur, Spain). OO were incorporated into capsules containing 0.5 g of oil, identical appearance to BMSO. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily.
Primary Outcome Measure Information:
Title
Weight gain
Description
Changes at intervention for 4,8 and 12 week
Time Frame
12 week
Secondary Outcome Measure Information:
Title
BMI
Description
Changes at intervention for 4,8 and 12 week
Time Frame
12 wk
Title
waist-to hip ratio
Description
Changes at intervention for 4,8 and 12 week
Time Frame
12 wk
Title
body fat mass
Description
Changes at intervention for 4,8 and 12 week
Time Frame
12 wk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
adults with overweight or obesity (BMI ≥ 24 kg/m2 or waist circumference > 90 cm in males and > 80 cm in females)
20-64 y of age
not currently using any weight-reducing agent
Exclusion Criteria:
diabetes
endocrine disease
uncontrolled high blood pressure (systolic ≥ 180 mm Hg or diastolic ≥ 110 mm Hg)
liver, kidney, or cardiovascular disease
gastrointestinal disease
psychological diseases
pregnancy or lactation
asthma and allergies
smoking
use of any drugs or dietary supplements that potentially affected body weight, blood lipids, blood pressure, or inflammatory responses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Min Chao, PhD
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Bitter Melon Seed Oil on Body Weight
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