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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-glucans | Active Comparator | Beta-glucans, 3 g per day, per 8 weeks, at breakfast |
|
| Placebo | Placebo Comparator | Placebo, 3 g per day, per 8 weeks, at breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-glucans | Dietary Supplement | Placebo consumption at breakfast (3 g per day) |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Borghi, MD | S. Orsola-Malpighi University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S. Orsola-Malpighi University Hospital | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Placebo |
| Dietary Supplement |
Placebo consumption at breakfast (3 g per day) |
|
| 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) |