Effect of Bitter Melon Seed Oil on Body Weight
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 11/30/2018 |
| Primero enviado: | 12/12/2018 |
| Inscripción estimada enviada: | 12/19/2018 |
| Publicado por primera vez: | 12/23/2018 |
| Última actualización enviada: | 12/19/2018 |
| Última actualización publicada: | 12/23/2018 |
| Fecha de inicio real del estudio: | 03/31/2016 |
| Fecha estimada de finalización primaria: | 03/31/2017 |
| Fecha estimada de finalización del estudio: | 03/31/2017 |
Condición o enfermedad
Intervención / tratamiento
Dietary Supplement: BMSO
Dietary Supplement: OO
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| 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. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 20 Years A 20 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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. |
Salir
Medidas de resultado primarias
1. Weight gain [12 week]
Medidas de resultado secundarias
1. BMI [12 wk]
2. waist-to hip ratio [12 wk]
3. body fat mass [12 wk]
