Back to resultsCheese Intake and Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CLA enriched cheese
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, Endocannabinoids
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
regular cheese
Arm Description
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
Outcomes
Primary Outcome Measures
modification of LDL-cholesterol levels
Secondary Outcome Measures
Full Information
NCT ID
NCT01570270
First Posted
March 23, 2012
Last Updated
April 3, 2012
Sponsor
Azienda Ospedaliera Brotzu
1. Study Identification
Unique Protocol Identification Number
NCT01570270
Brief Title
Cheese Intake and Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Brotzu
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hypercholesterolemia, Endocannabinoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
regular cheese
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
CLA enriched cheese
Intervention Description
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.
Primary Outcome Measure Information:
Title
modification of LDL-cholesterol levels
Time Frame
baseline and 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Cheese Intake and Hypercholesterolemia
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