Cheese Intake and Hypercholesterolemia

Sponsor

Azienda Ospedaliera Brotzu (Other)

Overall Status

Completed

CT.gov ID

NCT01570270

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Dietary Supplement: CLA enriched cheese	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

modification of LDL-cholesterol levels [baseline and 3 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Ospedaliera Brotzu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefano Pintus, Principal Investigator, Azienda Ospedaliera Brotzu

ClinicalTrials.gov Identifier:

NCT01570270

Other Study ID Numbers:

CASU

First Posted:

Apr 4, 2012

Last Update Posted:

Apr 4, 2012

Last Verified:

Apr 1, 2012

Keywords provided by Stefano Pintus, Principal Investigator, Azienda Ospedaliera Brotzu

Hypercholesterolemia

Endocannabinoids

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Apr 4, 2012