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Cheese Intake and Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT01570270
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Sponsor:
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 alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: CLA enriched cheese Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : May 2009
Primary Completion Date : December 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: regular 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
Dietary Supplement: CLA enriched cheese
This study was a 3-week, randomized, single 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.



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


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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:

  • 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.

Responsible Party: Stefano Pintus, Principal Investigator, Azienda Ospedaliera Brotzu
ClinicalTrials.gov Identifier: NCT01570270     History of Changes
Other Study ID Numbers: CASU
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Stefano Pintus, Azienda Ospedaliera Brotzu:
Hypercholesterolemia
Endocannabinoids

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases