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

Not Applicable

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: Beta-glucans; Dietary Supplement: Placebo

• Registration Number: NCT03313713
• Lead Sponsor: University of Bologna

Brief Summary

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

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

Study Timeline

• Study Start: 2017-04-26
• Status Verified: 2017-10
• Study First Submitted: 2017-10-08
• Study First Submitted QC: 2017-10-12
• Last Update Submitted: 2017-10-17
• Study First Posted: 2017-10-18
• Last Update Posted: 2017-10-19
• Primary Completion: 2017-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Beta-glucans	Beta-glucans	Beta-glucans, 3 g per day, per 8 weeks, at breakfast
Placebo	Placebo	Placebo, 3 g per day, per 8 weeks, at breakfast

Primary Outcome Measures

Name	Time	Method
12 hour fasting lipid profile change from the baseline to the end of the intervention period	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	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 Outcome Measures

Name	Time	Method
Intestinal function from the baseline to the end of the intervention period	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	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	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)

Trial Locations

Locations (1)

S. Orsola-Malpighi University Hospital; 🇮🇹 Bologna, BO, Italy