Effect of Bitter Melon Seed Oil on Body Weight
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|ClinicalTrials.gov Identifier: NCT03785821|
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Weight Gain||Dietary Supplement: BMSO Dietary Supplement: OO||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- Weight gain [ Time Frame: 12 week ]Changes at intervention for 4,8 and 12 week
- BMI [ Time Frame: 12 wk ]Changes at intervention for 4,8 and 12 week
- waist-to hip ratio [ Time Frame: 12 wk ]Changes at intervention for 4,8 and 12 week
- body fat mass [ Time Frame: 12 wk ]Changes at intervention for 4,8 and 12 week
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785821
|Principal Investigator:||Pei-Min Chao, PhD||China Medical University, China|