Effect of Bitter Melon Seed Oil on Body Weight

• ClinicalTrials.gov Identifier: NCT03785821
• Recruitment Status: Completed
• First Posted: December 24, 2018
• Last Update Posted: December 24, 2018
• Sponsor: China Medical University Hospital
• Information provided by (Responsible Party): China Medical University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Weight Gain	Dietary Supplement: BMSO; Dietary Supplement: OO	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Development and Clinical Application of Bitter Melon Seed Oil as a Functional Food for Treating Obesity and Hepatic Steatosis
• Actual Study Start Date: April 1, 2016
• Actual Primary Completion Date: April 1, 2017
• Actual Study Completion Date: April 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: BMSO; Bitter melon seed oil supplementation	Dietary Supplement: BMSO; 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.
Placebo Comparator: OO; Olive oil supplementation	Dietary Supplement: OO; 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.

Outcome Measures

Primary Outcome Measures :

1. Weight gain [ Time Frame: 12 week ]
   Changes at intervention for 4,8 and 12 week

Secondary Outcome Measures :

1. BMI [ Time Frame: 12 wk ]
   Changes at intervention for 4,8 and 12 week
2. waist-to hip ratio [ Time Frame: 12 wk ]
   Changes at intervention for 4,8 and 12 week
3. body fat mass [ Time Frame: 12 wk ]
   Changes at intervention for 4,8 and 12 week

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

China Medical University Hospital

Investigators

• Principal Investigator: Pei-Min Chao, PhD; China Medical University, China

More Information

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT03785821
• Other Study ID Numbers: CMUH104-REC3-014
• First Posted: December 24, 2018
• Last Update Posted: December 24, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:

Bitter melon seed oil; Olive oil; Weight control; UCP1 polymorphism

Additional relevant MeSH terms:

Weight Gain; Body Weight; Body Weight Changes