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Cheese Intake,CLA and Hypercholesterolemia (CASU)

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ClinicalTrials.gov Identifier: NCT01561846
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : March 23, 2012
Sponsor:
Collaborator:
University of Cagliari
Information provided by (Responsible Party):
Stefano Pintus, Azienda Ospedaliera Brotzu

Brief 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.

Condition or disease Intervention/treatment Phase
Modifications of LDL Cholesterol Modifications of Enocannabinoid Levels Dietary Supplement: CLA enriched cheese Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Controlled, Cross Over Clinical Trial on Intake of CLA Enriched Cheese in Hypercholesterolemic Patients
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
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



Primary Outcome Measures :
  1. decrease of LDL-cholesterol levels [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. endocannabinoid levels [ Time Frame: 3 weeks ]
    Modification of endocannabinoid levels during intake of CLA enriched cheese.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561846


Locations
Italy
Metabolic diseases Center AOBrotzu
Cagliari, Italy, 091341
Sponsors and Collaborators
Azienda Ospedaliera Brotzu
University of Cagliari
Investigators
Study Chair: Sebastiano Banni, PHD Department of biomedical sciences University of Cagliari, Italy

Responsible Party: Stefano Pintus, Medical Doctor, Azienda Ospedaliera Brotzu
ClinicalTrials.gov Identifier: NCT01561846     History of Changes
Other Study ID Numbers: AOBROTZUCMDA
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by Stefano Pintus, Azienda Ospedaliera Brotzu:
Conjugated Linoleic Acid
LDL-cholesterol
Endocannabinoids