Modifications of Enocannabinoid Levels Clinical Trial
— CASUOfficial title:
Randomized, Double Blind, Controlled, Cross Over Clinical Trial on Intake of CLA Enriched Cheese in Hypercholesterolemic Patients
| Verified date | March 2012 |
| Source | Azienda Ospedaliera Brotzu |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: ethic committee A.O.Brotzu |
| Study type | Interventional |
In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | March 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Adult volunteers with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL) Exclusion Criteria: - Pregnant (or those planning to become pregnant during the study period) and lactating women - Also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit. - Those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening. - Volunteers with the following characteristics were also excluded: - total cholesterol =300 mg/dL, serum triglycerides =250 mg/dL or = 200 mg/dL, *HDL =70mg/dL, BMI = 30 - uncontrolled hypertension (systolic blood pressure =160 mm Hg or diastolic blood pressure =100 mm Hg) at screening. - Use of lipid-altering medications or supplements, and of anticoagulants, during the 2 weeks before screening and throughout the study was prohibited. - Furthermore, we selected subjects with an Apo E aplotype 3/3, the most common in Sardinia, in order to avoid any variability in cholesterolemia due to a different dietary response. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Metabolic diseases Center AOBrotzu | Cagliari |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Ospedaliera Brotzu | University of Cagliari |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | decrease of LDL-cholesterol levels | 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL), 30-60 years of age, were recruited.Individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit were excluded. Volunteers with the following characteristics were also excluded: total cholesterol =300 mg/dL, serum triglycerides =250 mg/dL or = 200 mg/dL, HDL =70mg/dL, BMI = 30, or uncontrolled hypertension at screening. | 3 weeks | Yes |
| Secondary | endocannabinoid levels | Modification of endocannabinoid levels during intake of CLA enriched cheese. | 3 weeks | No |