Clinical trial NCT03313713: Beta-glucan Effects on Lipid Profile, Glycemia and inTestinal Health (BELT)
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 85
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 12 hour fasting lipid profile change from the baseline to the end of the intervention period
timeFrame: 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)
measure: 12 hour fasting glycemia change from the baseline to the end of the intervention period
timeFrame: 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 outcomes:
measure: Intestinal function from the baseline to the end of the intervention period
timeFrame: 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)
measure: Liver function markers (glutamic oxalacetic transaminase, alanine transaminase, glutamic-pyruvic transaminase, aspartate transaminase) change from the baseline to the end of the intervention period
timeFrame: 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)
measure: Blood pressure change from the baseline to the end of the intervention period
timeFrame: 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)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
state: BO
Study officials:
affiliation: S. Orsola-Malpighi University Hospital
name: Claudio Borghi, MD
role: PRINCIPAL_INVESTIGATOR
References: