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

NCT ID: NCT03313713

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2018-03-31

Brief Summary

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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

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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

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Beta-glucans

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

Group Type ACTIVE_COMPARATOR

Beta-glucans

Intervention Type DIETARY_SUPPLEMENT

Placebo consumption at breakfast (3 g per day)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo consumption at breakfast (3 g per day)

Interventions

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Beta-glucans

Placebo consumption at breakfast (3 g per day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo consumption at breakfast (3 g per day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Claudio Borghi

Chief Internal Medicine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio Borghi, MD

Role: PRINCIPAL_INVESTIGATOR

S. Orsola-Malpighi University Hospital

Locations

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S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Site Status

Countries

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Italy

Other Identifiers

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BELT_2016

Identifier Type: -

Identifier Source: org_study_id