Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans

NCT00933322 | Terminated DMC

• 1 other identifier: KEK 124/09
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare a diet rich in trans fatty acids (TFA) from ruminant sources with a diet rich in TFA from hydrogenated vegetable oils (PHVO) in regard to their effects on cardiovascular risk markers (endothelial function, blood lipids, inflammation and coagulation parameters in the blood). After a two week run-in period (diet without TFA) volunteers are randomized into three groups with different diets: diet rich in TFA from ruminant sources, diet rich in TFA from PHVO and diet without TFA. The intervention period lasts four weeks. A nutritionist introduces the basic issues of the study diets. All volunteers supply themselves according to the recommendations of the Swiss food pyramid. Fat free food can be chosen individually in the context of defined guidelines. The amount and source of the fat in the diet are strictly defined. During the whole study, volunteers meet the nutritionist every 2 weeks, and in the weeks between, the volunteers are contacted by phone. The volunteers will continue their normal daily life and physical activities. At the beginning of the run-in period and at the beginning and the end of the intervention period the endothelial function of the brachial artery will be assessed using flow-mediated dilation (FMD)/nitro-mediated dilation (NMD) methods and blood samples will be collected to analyze blood lipids, inflammation and coagulation parameters in the blood. Hypothesis:

1. 1.Diet enriched with ruminant TFA has not the same negative effect on cardiovascular risk markers as diet enriched with the same amount of industrial TFA compared with a diet without TFA.
2. 2.Diet enriched with ruminant TFA has not a more negative effect on cardiovascular risk markers as diet without TFA.

Conditions

Healthy

Keywords

ruminant; industrial; endothelial function; flow-mediated dilation; blood lipids; nutrition; trans fatty acids; coronary disease; endothelial function of the brachial artery; inflammation; insulin resistancy; coagulation

Outcome Measures

Primary Outcomes (1)

• endothelial function using flow-mediated dilation

  3 time points over 6 weeks (after 0, 2, 6 weeks)

Secondary Outcomes (5)

• inflammation parameters in blood samples

  6 weeks

• coagulation parameters in blood samples

  6 weeks

• blood lipids in blood samples

  6 weeks

• adhesion molecules in blood samples

  6 weeks

• insulin resistance via blood samples

  6 weeks

Study Arms (3)

ruminant TFA

ACTIVE COMPARATOR

In addition to the basic diet, volunteers enrich their diet with an individually calculated amount of butter containing ruminant TFA and with 15-20g rape oil for balancing the essential fatty acids.

Dietary Supplement: diet enriched with ruminant trans fatty acids

industrial TFA

ACTIVE COMPARATOR

In addition to the basic diet, volunteers enrich their diet with an individually calculated amount of butter containing TFA from PHVO and with 15-20g rape oil for balancing the essential fatty acids.

Dietary Supplement: diet enriched with industrial trans fatty acids

without TFA

PLACEBO COMPARATOR

In addition to the basic diet, volunteers enrich their diet with an individually calculated amount of butter without TFA and with 15-20g rape oil for balancing the essential fatty acids.

Dietary Supplement: diet without any trans fatty acids

Interventions

diet enriched with industrial trans fatty acids DIETARY_SUPPLEMENT

After run-in phase of 2 weeks with margarine without TFA, 4 weeks with margarine enriched with industrial trans fatty acids following. TFA-percentage of total energy consumption is 2% or 6% of total fat energy consumption.

industrial TFA

diet enriched with ruminant trans fatty acids DIETARY_SUPPLEMENT

After run-in phase of 2 weeks with margarine without TFA, 4 weeks with butter enriched with ruminant trans fatty acids following. TFA-percentage of total energy consumption is 2% or 6% of total fat energy consumption.

ruminant TFA

diet without any trans fatty acids DIETARY_SUPPLEMENT

6 weeks with margarine without any trans fatty acids.

without TFA

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-69
• body mass index 20-30 kg/m2
• willingness to hold physical activity constant over study duration
• written informed consent

You may not qualify if:

• smoking
• hypertension (\> 140/90 mm Hg)
• hypotension (men \< 115 mm Hg; women \< 105 mm Hg)
• obesity (BMI =/\> 30 kg/m2)
• vegan
• infections in the last 6 weeks
• allergy for food (e.g., milk)
• pregnancy
• diabetes (elevated fasting blood glucose level)
• clinical known coronary diseases
• acute and/or chronical medication (incl. contraceptive)
• abnormal kidney function
• abnormal liver function
• known cardiac arrhythmia (e.g., atrial fibrillation)
• blood parameters (ALAT, Creatinin, Hb, potassium, CRP) in range

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Agroscope Liebefeld-Posieux Research Station ALP: collaborator
• University of Bern: collaborator
• Schweizerische Herzstiftung: collaborator
• Bundesamt für Landwirtschaft: collaborator
• Emmi Schweiz AG: collaborator

Study Sites (1)

Cardiovascular Prevention and Rehabilitation, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 16611951 BACKGROUND

• Ascherio A, Katan MB, Zock PL, Stampfer MJ, Willett WC. Trans fatty acids and coronary heart disease. N Engl J Med. 1999 Jun 24;340(25):1994-8. doi: 10.1056/NEJM199906243402511. No abstract available.

  PMID: 10379026 BACKGROUND

• 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.

  PMID: 8094827 BACKGROUND

• Moens AL, Goovaerts I, Claeys MJ, Vrints CJ. Flow-mediated vasodilation: a diagnostic instrument, or an experimental tool? Chest. 2005 Jun;127(6):2254-63. doi: 10.1378/chest.127.6.2254.

  PMID: 15947345 BACKGROUND

• Mozaffarian D, Aro A, Willett WC. Health effects of trans-fatty acids: experimental and observational evidence. Eur J Clin Nutr. 2009 May;63 Suppl 2:S5-21. doi: 10.1038/sj.ejcn.1602973.

  PMID: 19424218 RESULT

• 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.

  PMID: 18326592 RESULT

• 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.

  PMID: 18326596 RESULT

• Guggisberg D, Burton-Pimentel KJ, Walther B, Badertscher R, Blaser C, Portmann R, Schmid A, Radtke T, Saner H, Fournier N, Butikofer U, Vergeres G. Molecular effects of the consumption of margarine and butter varying in trans fat composition: a parallel human intervention study. Lipids Health Dis. 2022 Aug 18;21(1):74. doi: 10.1186/s12944-022-01675-1.

  PMID: 35982449 DERIVED

• Radtke T, Schmid A, Trepp A, Dahler F, Coslovsky M, Eser P, Wilhelm M, Saner H. Short-term effects of trans fatty acids from ruminant and industrial sources on surrogate markers of cardiovascular risk in healthy men and women: A randomized, controlled, double-blind trial. Eur J Prev Cardiol. 2017 Mar;24(5):534-543. doi: 10.1177/2047487316680691. Epub 2016 Dec 5.

  PMID: 27899529 DERIVED

MeSH Terms

Conditions

Coronary Disease; Inflammation; Thrombosis

Interventions

Diet

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hugo Saner, Prof. Dr. med

  Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland

  STUDY DIRECTOR

• Alexandra Schmid, Dipl. oec. troph.

  Agroscope Liebefeld-Posieux Research Station ALP, Posieux, Switzerland

  STUDY DIRECTOR

• Thomas Radtke, MSc

  Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

CH (1)