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Cardiovascular DiseaseTRANSWNCT00930137

Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women

A study testing isocaloric for week diet in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk factors has not been as well characterized. Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
isocaloric for week diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteCanada
Study dates
Sep 2009to Sep 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy women using or not contraceptive agents or hormone supplementation
  • For pre-menopausal women: regular menstrual cycle for the last 3 months (25- 35 days)
  • LDL-Cholesterol concentration between 2.5 and 4.0 mmol/L
  • Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
  • Smoking or not

Who cannot join

  • Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
  • Subjects taking medications for hyperlipidemia or hypertension
  • Endocrine disorders
  • Body mass index > 35 kg/m2
  • Food allergies
  • Women with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
  • Elite athletes

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk factors has not been as well characterized. We have previously shown in men that a very high dietary intakes of rTFA (>3.5% of energy) leads to unfavourable changes in lipid cardiovascular risk factors that are similar to those seen with iTFA. However, our data also indicated that achievable intakes of rTFA that remain well above the current human consumption (1.5% of energy intake) had neutral effects on plasma lipids and other cardiovascular disease (CVD) risk factors in men. Other studies have also suggested that the LDL and HDL response to very high dietary intakes of rTFA (>5% of energy) in women may be different than in men.

The general objective of the study is to investigate for the first time in a double-blind randomized controlled study the impact of high but yet achievable intake of ruminant trans fatty acids on plasma LDL-Cholesterol and other risk factors for CVD in healthy women.

Read the detailed description

Ruminant trans fatty acids (rTFA) will come from an experimental butter formulated from dairy fat obtained after having modified the regimen of lactating cows. All diets will be identical in terms of menus, calories and macronutrient composition with the exception of TFA levels. All foods will be provided to study participants. Based on a 2500 kcal/day regimen, an intake of 4.1g of rTFA will represent 37 kcal/day (1.5% of energy intake) while the intake of 0.7 g of rTFA in the control diet will represent 6 calories (0.3% of energy). The 2 experimental diets will be formulated so that the percentage of daily calories from fat (33%), carbohydrates (52%) and proteins (15%) will meet the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD.

Being tested
isocaloric for week diet
Keywords
Cardiovascular disease, Trans fatty acids, Ruminant, Blood lipids, Lipoproteins, Women
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • isocaloric for week dietOther

    Consumption of the 2 experimental diets

    1. a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);
    2. a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).
Study groups in NCT00930137
Study groupRoleWhat they receive
High dairy trans fatExperimentala diet rich in ruminant trans fatty acids (4.1 g/2500 kcal)
Receives: Other: isocaloric for week diet
Low dairy trans fat dietActive comparatora control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal)
Receives: Other: isocaloric for week diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma LDL-Cholesterol concentrations

    Measured: At the beginning of the study and the end of the 2 for-week diets

Secondary outcomes (4)

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

    Measured: At the beginning of the study and the end of the 2 for-week diets

  2. CRP

    Measured: At the beginning of the study and the end of the 2 for-week diets

  3. Blood pressure

    Measured: At the beginning of the study and the end of the 2 for-week diets

  4. Anthropometric measures (waist and hip circumferences)

    Measured: At the beginning of the study and the end of the 2 for-week diets

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2010
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930137
Sponsor's protocol ID
INAF-2009-084
Acronym
TRANSW
Status last verified
Mar 2013
First submitted
29 Jun 2009
Last updated
5 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • Motard-Belanger A, Charest A, Grenier G, Paquin P, Chouinard Y, Lemieux S, Couture P, Lamarche B. Study of the effect of trans fatty acids from ruminants on blood lipids and other risk factors for cardiovascular disease. Am J Clin Nutr. 2008 Mar;87(3):593-9. doi: 10.1093/ajcn/87.3.593.

    PubMed 18326596

  • Desroches S, Chouinard PY, Galibois I, Corneau L, Delisle J, Lamarche B, Couture P, Bergeron N. Lack of effect of dietary conjugated linoleic acids naturally incorporated into butter on the lipid profile and body composition of overweight and obese men. Am J Clin Nutr. 2005 Aug;82(2):309-19. doi: 10.1093/ajcn.82.2.309.

    PubMed 16087973

  • Mauger JF, Lichtenstein AH, Ausman LM, Jalbert SM, Jauhiainen M, Ehnholm C, Lamarche B. Effect of different forms of dietary hydrogenated fats on LDL particle size. Am J Clin Nutr. 2003 Sep;78(3):370-5. doi: 10.1093/ajcn/78.3.370.

    PubMed 12936917

  • Lichtenstein AH, Ausman LM, Jalbert SM, Schaefer EJ. Effects of different forms of dietary hydrogenated fats on serum lipoprotein cholesterol levels. N Engl J Med. 1999 Jun 24;340(25):1933-40. doi: 10.1056/NEJM199906243402501.

    PubMed 10379016

  • Chardigny JM, Destaillats F, Malpuech-Brugere C, Moulin J, Bauman DE, Lock AL, Barbano DM, Mensink RP, Bezelgues JB, Chaumont P, Combe N, Cristiani I, Joffre F, German JB, Dionisi F, Boirie Y, Sebedio JL. Do trans fatty acids from industrially produced sources and from natural sources have the same effect on cardiovascular disease risk factors in healthy subjects? Results of the trans Fatty Acids Collaboration (TRANSFACT) study. Am J Clin Nutr. 2008 Mar;87(3):558-66. doi: 10.1093/ajcn/87.3.558.

    PubMed 18326592

  • Tholstrup T, Raff M, Basu S, Nonboe P, Sejrsen K, Straarup EM. Effects of butter high in ruminant trans and monounsaturated fatty acids on lipoproteins, incorporation of fatty acids into lipid classes, plasma C-reactive protein, oxidative stress, hemostatic variables, and insulin in healthy young men. Am J Clin Nutr. 2006 Feb;83(2):237-43. doi: 10.1093/ajcn/83.2.237.

    PubMed 16469980

  • Oomen CM, Ocke MC, Feskens EJ, van Erp-Baart MA, Kok FJ, Kromhout D. Association between trans fatty acid intake and 10-year risk of coronary heart disease in the Zutphen Elderly Study: a prospective population-based study. Lancet. 2001 Mar 10;357(9258):746-51. doi: 10.1016/s0140-6736(00)04166-0.

    PubMed 11253967

  • Mozaffarian D, Katan MB, Ascherio A, Stampfer MJ, Willett WC. Trans fatty acids and cardiovascular disease. N Engl J Med. 2006 Apr 13;354(15):1601-13. doi: 10.1056/NEJMra054035. No abstract available.

    PubMed 16611951

  • Willett WC, Stampfer MJ, Manson JE, Colditz GA, Speizer FE, Rosner BA, Sampson LA, Hennekens CH. Intake of trans fatty acids and risk of coronary heart disease among women. Lancet. 1993 Mar 6;341(8845):581-5. doi: 10.1016/0140-6736(93)90350-p.

    PubMed 8094827

  • Willett W, Mozaffarian D. Ruminant or industrial sources of trans fatty acids: public health issue or food label skirmish? Am J Clin Nutr. 2008 Mar;87(3):515-6. doi: 10.1093/ajcn/87.3.515. No abstract available.

    PubMed 18326587

  • Lacroix E, Charest A, Cyr A, Baril-Gravel L, Lebeuf Y, Paquin P, Chouinard PY, Couture P, Lamarche B. Randomized controlled study of the effect of a butter naturally enriched in trans fatty acids on blood lipids in healthy women. Am J Clin Nutr. 2012 Feb;95(2):318-25. doi: 10.3945/ajcn.111.023408. Epub 2011 Dec 28.

    PubMed 22205319

Questions about this trial

What is this clinical trial studying?

A study testing isocaloric for week diet in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma LDL-Cholesterol concentrations (time frame: At the beginning of the study and the end of the 2 for-week diets). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930137, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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