Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)

Overview

This will be a randomized, placebo-controlled, clinical trial carried out on moderately hypercholesterolemic subjects who will consume 3 g per day of beta-glucans, in order to evaluate the effects on lipid profile, glycemia and intestinal function

Full Title of Study: “Randomised Placebo-Controlled Clinical Trial to Assess the Medium-term Effect of 3 g/Day of a Beta-glucan on Lipid Profile, Glycemia and Intestinal Health, in Moderately Hypercholesterolemic Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2017

Detailed Description

In order to assess the mid term effects of beta-glucans on lipid profile, glycemia and intestinal function, moderately hypercholesterolemic subjects will be involved in a cross-over study and supplemented for 8 weeks with 3 g/day of beta-glucans or placebo. The two intervention periods will be spaced by a 4 week washout period

Interventions

  • Dietary Supplement: Beta-glucans
    • Placebo consumption at breakfast (3 g per day)
  • Dietary Supplement: Placebo
    • Placebo consumption at breakfast (3 g per day)

Arms, Groups and Cohorts

  • Active Comparator: Beta-glucans
    • Beta-glucans, 3 g per day, per 8 weeks, at breakfast
  • Placebo Comparator: Placebo
    • Placebo, 3 g per day, per 8 weeks, at breakfast

Clinical Trial Outcome Measures

Primary Measures

  • 12 hour fasting lipid profile change from the baseline to the end of the intervention period
    • Time Frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
  • 12 hour fasting glycemia change from the baseline to the end of the intervention period
    • Time Frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)

Secondary Measures

  • Intestinal function from the baseline to the end of the intervention period
    • Time Frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
    • Intestinal function will be assessed by the use of a scale questionnaire investigating the number of weekly bowel movements, stool consistency, ease of defecation, sensation of emptying after defecation, intensity of discomfort during the defecation, feeling of bloating.
  • Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period
    • Time Frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)
  • Blood pressure change from the baseline to the end of the intervention period
    • Time Frame: At the screening visit (4 weeks before the randomization one), at the randomization visit (week 0), after 4 and 8 weeks of treatment in both intervention periods (up to 24 weeks overall)

Participating in This Clinical Trial

Inclusion Criteria

  • Total cholesterol between 200 and 240 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
  • Triglycerides lower than 200 mg/dL
  • Cardiovascular risk at 10 years lower than 10%
  • Informed consent

Exclusion Criteria

  • Secondary prevention for cardiovascular diseases
  • TG > 400 mg/dL, HDL-C < 35 mg/dL
  • BMI higher than 30
  • Assumption of lipid lowering drug or supplement with fibre or probiotics during the last 2 months
  • Alcohol abuse
  • Food allergy
  • Alterations in thyroid, liver, or kidney functions, muscle diseases
  • Diabetes, irritable bowel syndrome or chronic disturbed gut function

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Bologna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudio Borghi, Chief Internal Medicine Unit – University of Bologna
  • Overall Official(s)
    • Claudio Borghi, MD, Principal Investigator, S. Orsola-Malpighi University Hospital

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