Cheese Intake and Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570270
• Other study ID #: CASU
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 23, 2012
• Last updated: April 3, 2012
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2012
• Source: Azienda Ospedaliera Brotzu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Brotzu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modification of LDL-cholesterol levels		baseline and 3 weeks	Yes