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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
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 13, 2018
    Last Updated
    December 20, 2018
    Sponsor
    China Medical University Hospital
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    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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