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Cheese Intake and Hypercholesterolemia

Phase 1
Completed
Conditions
Hypercholesterolemia
Registration Number
NCT01570270
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
modification of LDL-cholesterol levelsbaseline and 3 weeks
Secondary Outcome Measures
NameTimeMethod

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