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

University of Bologna

Status: Unknown

Conditions: Atherosclerosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Beta-glucans

Study type: Interventional

Funder types: Other

Identifiers

NCT03313713

BELT_2016

Details and patient eligibility

About

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 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

Enrollment: 85 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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85 participants in 2 patient groups, including a placebo group

Beta-glucans

Active Comparator group

Description:

Beta-glucans, 3 g per day, per 8 weeks, at breakfast

Treatment:

Dietary Supplement: Beta-glucans

Placebo

Placebo Comparator group

Description:

Placebo, 3 g per day, per 8 weeks, at breakfast

Treatment:

Dietary Supplement: Placebo