Study of the Impact of Trans Fatty Acids From Dairy Products on Cardiovascular Risk Factors (TRANS)

This study has been completed.
Sponsor:
Collaborators:
Dairy Farmers of Canada
Novalait Inc
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT01163175
First received: July 9, 2010
Last updated: February 10, 2011
Last verified: July 2010

July 9, 2010
February 10, 2011
May 2006
July 2007   (final data collection date for primary outcome measure)
Plasma LDL-Cholesterol concentrations [ Time Frame: At the beginning and the end of the 4 for-week diets ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01163175 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Markers of inflammation (C-reactive protein) [ Time Frame: At the beginning and the end of the 4 for-week diets ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: At the beginning and the end of the 4 for-week diets ] [ Designated as safety issue: No ]
  • Anthropometric measures (waist and hip circumferences) [ Time Frame: At the beginning and the end of the 4 for-week diets ] [ Designated as safety issue: No ]
  • Surrogates of cholesterol absorption and synthesis [ Time Frame: At the beginning and the end of the 4 for-week diet ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Impact of Trans Fatty Acids From Dairy Products on Cardiovascular Risk Factors
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.

The proposed research will be undertaken as a double-blind randomized cross-over study according to a Latin Square design, with participants being subjected to 4 consecutive isocaloric diets in random order lasting 4 weeks each. No stratification is considered since the population recruited will be relatively homogeneous. The 4 experimental diets are: 1- a diet rich in ruminant TFA (8 g/day); 2- a diet moderately rich in ruminant TFA (4 g/day); 3- a diet rich in industrial TFA (8 g/d); 4- a control diet (minimal dietary TFA of industrial and ruminant sources). The source of ruminant TFA will come from butter and cream obtained after having modified the regimen of lactating cows in a fashion similar to the one used to increase the levels of conjugated linoleic acid (CLA) in milk fat. Hydrogenated margarine will be used as the main source of industrial TFA. Finally, a butter obtained from cows producing the lowest levels of ruminant fat will be used to formulate the control diet (minimal dietary TFA). All diets will be identical in terms of menus, calories and macronutrient composition with the exception of TFA sources and levels. Minor differences in the levels of total saturated, monounsaturated and polyunsaturated fatty acids will be matched across diets by adding various vegetable and animal oils. The macronutrient composition of each meal and thus of the entire day is very similar across all 4 diets. Based on a 2500 kcal/day regimen, an intake of TFA of 8 g/d and 4 g/d will represent 72 kcal/day and 36 kcal/day respectively (3% and 1.5% of energy intake). The 4 experimental diets will be formulated so that the percentage of daily calories from fat (36%), carbohydrates (50%) and proteins (14%) will meet most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of SAT (slight excess) and fibers (slight deficit). The slight excess in SAT fat cannot be avoided since we are using butter as the primary source of ruminant TFA. The cholesterol content of the experimental diet will not exceed 300 mg/day.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Disease
Other: Ruminant trans fats

Consumption of the 4 experimental diets:

  1. a diet rich in ruminant TFA (8 g/day);
  2. a diet moderately rich in ruminant TFA (4 g/day);
  3. a diet rich in industrial TFA (8 g/d);
  4. a control diet (minimal dietary TFA of industrial and ruminant sources).
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2007
July 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01163175
INAF-2005-233
No
Benoît Lamarche, PhD, Institute of Nutraceutical and Functional Foods (INAF), Laval University
Laval University
  • Dairy Farmers of Canada
  • Novalait Inc
Principal Investigator: Benoît Lamarche, PhD Laval University
Laval University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP