Cheese Intake and Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stefano Pintus, Azienda Ospedaliera Brotzu
ClinicalTrials.gov Identifier:
NCT01570270
First received: March 23, 2012
Last updated: April 3, 2012
Last verified: April 2012

March 23, 2012
April 3, 2012
May 2009
December 2009   (final data collection date for primary outcome measure)
modification of LDL-cholesterol levels [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01570270 on ClinicalTrials.gov Archive Site
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Cheese Intake and Hypercholesterolemia
Not Provided

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.

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Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypercholesterolemia
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.
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
Intervention: Dietary Supplement: CLA enriched cheese
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01570270
CASU
No
Stefano Pintus, Azienda Ospedaliera Brotzu
Azienda Ospedaliera Brotzu
Not Provided
Not Provided
Azienda Ospedaliera Brotzu
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP