Cheese Intake,CLA and Hypercholesterolemia (CASU)

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

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.

Study Overview

• Status: Completed
• Conditions: Modifications of LDL Cholesterol; Modifications of Enocannabinoid Levels
• Intervention / Treatment: Dietary supplement: CLA enriched cheese

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy, 091341
    • Metabolic diseases Center AOBrotzu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: regular cheese; This study was a 3-week, randomized, double blind, controlled, cross over clinical trialy. 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
Experimental: CLA enriched cheese	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endocannabinoid levels	Modification of endocannabinoid levels during intake of CLA enriched cheese.	3 weeks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Brotzu
• Collaborators: University of Cagliari
• Investigators: Study Chair: Sebastiano Banni, PHD, Department of biomedical sciences University of Cagliari, Italy

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): March 23, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Conjugated Linoleic Acid; LDL-cholesterol; Endocannabinoids
• Other Study ID Numbers: AOBROTZUCMDA