Cheese Intake and Hypercholesterolemia

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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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLA enriched cheese

Dietary Supplement

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.

Primary outcomes

modification of LDL-cholesterol levels

Time frame: baseline and 3 weeks

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Brotzu

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Apr 4, 2012
Registry last updated: Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed