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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
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
 Dietary Supplement: CLA enriched cheese
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Brotzu:

Primary Outcome Measures:
  • modification of LDL-cholesterol levels [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Stefano Pintus, Principal Investigator, Azienda Ospedaliera Brotzu
ClinicalTrials.gov Identifier: NCT01570270     History of Changes
Other Study ID Numbers: CASU
Study First Received: March 23, 2012
Last Updated: April 3, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda Ospedaliera Brotzu:
Hypercholesterolemia
Endocannabinoids

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

ClinicalTrials.gov processed this record on May 16, 2013