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

Study Overview
=================
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

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

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Beta-glucans
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beta-glucans<br>Beta-glucans, 3 g per day, per 8 weeks, at breakfast | Dietary Supplement: Beta-glucans<br>* Placebo consumption at breakfast (3 g per day)<br>|
| Placebo Comparator: Placebo<br>Placebo, 3 g per day, per 8 weeks, at breakfast | Dietary Supplement: Placebo<br>* Placebo consumption at breakfast (3 g per day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal function from the baseline to the end of the intervention period | 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. | 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) | 
| 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) |