Cheese Intake and Hypercholesterolemia

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: CLA enriched cheese

• Registration Number: NCT01570270
• Lead Sponsor: Azienda Ospedaliera Brotzu

Brief Summary

In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-12
• Study Completion: 2010-04
• Study First Submitted: 2012-03-23
• Status Verified: 2012-04
• Study First Submitted QC: 2012-04-03
• Last Update Submitted: 2012-04-03
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL),
• 30-60 years of age

Exclusion Criteria

• Pregnant (or those planning to become pregnant during the study period) and lactating women were excluded;

• 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.

• In addition, 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, were not enrolled.

• 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 (systolic blood pressure ≥ 160 mm Hg or
  • diastolic blood pressure ≥ 100 mm Hg) at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
regular cheese	CLA enriched cheese	This study was a 3-week, randomized, single blind, controlled, cross over clinical trial. 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. T

Primary Outcome Measures

Name	Time	Method
modification of LDL-cholesterol levels	baseline and 3 weeks