Cheese Intake,CLA and Hypercholesterolemia

NCT01561846 | Completed Phase 1

• 1 other identifier: AOBROTZUCMDA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double 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.

Conditions

Modifications of LDL Cholesterol; Modifications of Enocannabinoid Levels

Keywords

Conjugated Linoleic Acid; LDL-cholesterol; Endocannabinoids

Outcome Measures

Primary Outcomes (1)

• decrease of LDL-cholesterol levels

  42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL), 30-60 years of age, were recruited.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 were excluded. 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 at screening.

  3 weeks

Secondary Outcomes (1)

• endocannabinoid levels

  3 weeks

Study Arms (2)

regular cheese

ACTIVE COMPARATOR

This study was a 3-week, randomized, double blind, controlled, cross over clinical trialy. 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. This procedure was subsequently repeated with a cheese intake of 45 g/d

Dietary Supplement: CLA enriched cheese

CLA enriched cheese

EXPERIMENTAL

Dietary Supplement: CLA enriched cheese

Interventions

CLA enriched cheese DIETARY_SUPPLEMENT

This study was a 3-week, randomized, double 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. This procedure was subsequently repeated with a cheese intake of 45 g/d

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 with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL)

You may not qualify if:

• Pregnant (or those planning to become pregnant during the study period) and lactating women
• 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.
• 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.
• 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
• uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
• Use of lipid-altering medications or supplements, and of anticoagulants, during the 2 weeks before screening and throughout the study was prohibited.
• Furthermore, we selected subjects with an Apo E aplotype 3/3, the most common in Sardinia, in order to avoid any variability in cholesterolemia due to a different dietary response.

Sponsors & Collaborators

• Azienda Ospedaliera Brotzu: lead
• University of Cagliari: collaborator

Study Sites (1)

Metabolic diseases Center AOBrotzu

Cagliari, 091341, Italy

Location

Study Officials

• Sebastiano Banni, PHD

  Department of biomedical sciences University of Cagliari, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 23, 2012
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 23, 2012

Record last verified: 2012-03

Locations

IT (1)