Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
- Registration Number
- NCT04321590
- Lead Sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Brief Summary
Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.
- Detailed Description
This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract. Four different supplements were formulated, containing 3 or 5 g of two types of beta-glucan, with 35% and 70% b-glucan content, together with 600 mg of the green coffee bean extract. Blind sachets were prepared containing half the daily dose of the supplement.
60 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 18-60 y old) were recruited and randomly assigned to one of the four intervention groups. Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks.
At the beginning and at the end of the study, volunteers came to the Human Nutrition Unit at the research center after an overnight fast. Urine and blood samples were obtained, blood pressure was measured and anthropometric measurements were performed. Dietary and physical activity records were collected.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Overweight/obese subjects (BMI 25-35 kg/m2)
- Smokers
- Pregnant women
- Medication/consumption of vitamins, dietary supplements, etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 g 35% beta-glucan Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) Supplement containing 5 g of 35% oat beta-glucan 3 g 35% beta-glucan Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) Supplement containing 3 g of 35% oat beta-glucan 3 g 70% beta-glucan Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) Supplement containing 3 g of 70% oat beta-glucan 5 g 70% beta-glucan Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg) Supplement containing 5 g of 70% oat beta-glucan
- Primary Outcome Measures
Name Time Method Anthropometric changes End of 6-week intervention Modification in body weight/percentage body fat
- Secondary Outcome Measures
Name Time Method Modification in blood lipids End of 6-week intervention Change in total or LDL-cholesterol levels or triglyceride levels
Trial Locations
- Locations (1)
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
🇪🇸Madrid, Spain