Cheese Intake and Hypercholesterolemia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Stefano Pintus, Azienda Ospedaliera Brotzu

ClinicalTrials.gov Identifier:

NCT01570270

First received: March 23, 2012

Last updated: April 3, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2012
Last Updated Date	April 3, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 3, 2012)	modification of LDL-cholesterol levels [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01570270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cheese Intake and Hypercholesterolemia
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Hypercholesterolemia
Intervention ^ICMJE	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.
Study Arm (s)	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 Intervention: Dietary Supplement: CLA enriched cheese
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	April 2010
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	30 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01570270
Other Study ID Numbers ^ICMJE	CASU
Has Data Monitoring Committee	No
Responsible Party	Stefano Pintus, Azienda Ospedaliera Brotzu
Study Sponsor ^ICMJE	Azienda Ospedaliera Brotzu
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Azienda Ospedaliera Brotzu
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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