Cheese Intake and Hypercholesterolemia

NCT01570270 | Completed Phase 1

• 1 other identifier: CASU
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Endocannabinoids

Outcome Measures

Primary Outcomes (1)

• modification of LDL-cholesterol levels

  baseline and 3 weeks

Study Arms (1)

regular cheese

EXPERIMENTAL

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

Interventions

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.

regular cheese

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL),
• years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Brotzu: lead

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 4, 2012
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 4, 2012

Record last verified: 2012-04