Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)

Overview

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.

Full Title of Study: “Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 20, 2017

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.

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)
    • Dose-response study on the effect of two different types of oat beta-glucan with different b-glucan content (35% vs. 70%) in combination with a green coffee bean extract rich in polyphenols. Consumption of 2 sachets/day (providing 3 or 5 g/d beta-glucan plus 600 mg polyphenols) during 6 weeks

Arms, Groups and Cohorts

  • Experimental: 3 g 35% beta-glucan
    • Supplement containing 3 g of 35% oat beta-glucan
  • Experimental: 5 g 35% beta-glucan
    • Supplement containing 5 g of 35% oat beta-glucan
  • Experimental: 3 g 70% beta-glucan
    • Supplement containing 3 g of 70% oat beta-glucan
  • Experimental: 5 g 70% beta-glucan
    • Supplement containing 5 g of 70% oat beta-glucan

Clinical Trial Outcome Measures

Primary Measures

  • Anthropometric changes
    • Time Frame: End of 6-week intervention
    • Modification in body weight/percentage body fat

Secondary Measures

  • Modification in blood lipids
    • Time Frame: End of 6-week intervention
    • Change in total or LDL-cholesterol levels or triglyceride levels

Participating in This Clinical Trial

Inclusion Criteria

  • Overweight/obese subjects (BMI 25-35 kg/m2)

Exclusion Criteria

  • Smokers
  • Pregnant women
  • Medication/consumption of vitamins, dietary supplements, etc.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Instituto de Ciencia y Tecnología de Alimentos y Nutrición
  • Collaborator
    • Ministerio de Economía y Competitividad, Spain
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura Bravo, Professor – Instituto de Ciencia y Tecnología de Alimentos y Nutrición
  • Overall Official(s)
    • Laura Bravo, Biologist, Principal Investigator, Research Professor

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