NCT01561846

Cheese Intake,CLA and Hypercholesterolemia

Randomized, Double Blind, Controlled, Cross Over Clinical Trial on Intake of CLA Enriched Cheese in Hypercholesterolemic Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Azienda Ospedaliera Brotzu · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Modifications of LDL Cholesterol
• Modifications of Enocannabinoid Levels

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CLA enriched cheese	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. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d
DIETARY_SUPPLEMENT	CLA enriched cheese	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. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2012-03-23
• Last updated: 2012-03-23

Locations

1 site across 1 country: Italy