Effect of Bitter Melon Seed Oil on Body Weight

NCT03785821 | Completed

• 1 other identifier: CMUH104-REC3-014
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Gain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Weight gain

  Changes at intervention for 4,8 and 12 week

  12 week

Secondary Outcomes (3)

• BMI

  12 wk

• waist-to hip ratio

  12 wk

• body fat mass

  12 wk

Study Arms (2)

BMSO

EXPERIMENTAL

Bitter melon seed oil supplementation

Dietary Supplement: BMSO

OO

PLACEBO COMPARATOR

Olive oil supplementation

Dietary Supplement: OO

Interventions

BMSO DIETARY_SUPPLEMENT

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.

BMSO

OO DIETARY_SUPPLEMENT

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.

OO

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults with overweight or obesity (BMI ≥ 24 kg/m2 or waist circumference \> 90 cm in males and \> 80 cm in females)
• y of age
• not currently using any weight-reducing agent

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-Min Chao, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 24, 2018
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share