Atherosclerosis
Conditions
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
Interventions
DIETARY_SUPPLEMENTBeta-glucans
Placebo consumption at breakfast (3 g per day)
DIETARY_SUPPLEMENTPlacebo
Placebo consumption at breakfast (3 g per day)
Sponsors
University of Bologna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed