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

NCT01163175 | Completed

• 1 other identifier: INAF-2005-233
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular disease; Trans fatty acids; Ruminant; Blood lipids

Outcome Measures

Primary Outcomes (1)

• Plasma LDL-Cholesterol concentrations

  At the beginning and the end of the 4 for-week diets

Secondary Outcomes (5)

• Blood lipids and apolipoproteins levels (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B)

  At the beginning and the end of the 4 for-week diets

• Markers of inflammation (C-reactive protein)

  At the beginning and the end of the 4 for-week diets

• Blood pressure

  At the beginning and the end of the 4 for-week diets

• Anthropometric measures (waist and hip circumferences)

  At the beginning and the end of the 4 for-week diets

• Surrogates of cholesterol absorption and synthesis

  At the beginning and the end of the 4 for-week diet

Interventions

Ruminant trans fats OTHER

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).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Dairy Farmers of Canada: collaborator
• Novalait Inc: collaborator

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Benoît Lamarche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 15, 2010
• Study Start: May 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 11, 2011

Record last verified: 2010-07

Locations

CA (1)