- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163175
Study of the Impact of Trans Fatty Acids From Dairy Products on Cardiovascular Risk Factors (TRANS)
Study of the Impact of Trans Fatty Acids From Dairy Products n Cardiovascular Risk Factors
The majority of trans fatty acids consumed by the general population is derived from products that have been formulated using significant amount of hydrogenated vegetable oil (the so-called industrial trans fat). Fat from ruminants also contains small amounts of trans fatty acid, which contribute, although to a smaller extent, to the total dietary intake of trans fatty acids in the general population. The negative impact of consuming industrial trans fat on health, particularly on cardiovascular disease, is being increasingly recognized. Based on data available to date, it is currently not possible to conclude if effects of ruminants and industrial trans fatty acid on cardiovascular risk are different. There is therefore an urgent need for a study that compares the impact of naturally occurring trans fatty acids such as those from dairy products and of trans fatty acids form industrial sources on cardiovascular risk factors as well as their mechanisms of action.
The general objective of the study is to investigate the impact of naturally occurring trans fatty acids from dairy products (mainly vaccenic acid) on plasma cholesterol levels and other risk factors for cardiovascular disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Quebec, Canada, G1V 0A6
- Institute of Nutraceutical and Functional Foods (INAF), Laval University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy men
- LDL-Cholesterol concentration <3.4 mmol/L
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Exclusion Criteria:
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Body mass index > 30 kg/m2
- Food allergies
- Men with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
- Elite athletes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma LDL-Cholesterol concentrations
Time Frame: At the beginning and the end of the 4 for-week diets
|
At the beginning and the end of the 4 for-week diets
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood lipids and apolipoproteins levels (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B)
Time Frame: At the beginning and the end of the 4 for-week diets
|
At the beginning and the end of the 4 for-week diets
|
Markers of inflammation (C-reactive protein)
Time Frame: At the beginning and the end of the 4 for-week diets
|
At the beginning and the end of the 4 for-week diets
|
Blood pressure
Time Frame: At the beginning and the end of the 4 for-week diets
|
At the beginning and the end of the 4 for-week diets
|
Anthropometric measures (waist and hip circumferences)
Time Frame: At the beginning and the end of the 4 for-week diets
|
At the beginning and the end of the 4 for-week diets
|
Surrogates of cholesterol absorption and synthesis
Time Frame: At the beginning and the end of the 4 for-week diet
|
At the beginning and the end of the 4 for-week diet
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INAF-2005-233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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