Cheese Intake and Hypercholesterolemia

Azienda Ospedaliera Brotzu

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: CLA enriched cheese

Study type: Interventional

Funder types: Other

Identifiers

NCT01570270

CASU

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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42 participants in 1 patient group

regular cheese

Experimental group

Description:

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

Treatment:

Dietary Supplement: CLA enriched cheese