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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014