HealthyNCT00933322
Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans
A study testing diet enriched with industrial trans fatty acids, diet enriched with ruminant trans fatty acids and diet without any trans fatty acids in people with Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- diet enriched with industrial trans fatty acids, diet enriched with ruminant trans fatty acids and diet without any trans fatty acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Jun 2013
- 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 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 45-69
- body mass index 20-30 kg/m2
- willingness to hold physical activity constant over study duration
- written informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiovascular Prevention and Rehabilitation, Bern University Hospital
Bern, Canton of Bern, 3010
About this study
Official title: Randomized-controlled Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans
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.
Read more
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:
- 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.
- Diet enriched with ruminant TFA has not a more negative effect on cardiovascular risk markers as diet without TFA.
Read the detailed description
Background:
For some time already negative effects of trans fatty acids (TFA) on the cardiovascular system are known. The main TFA sources in our nutrition are partly hydrogenated vegetable oils (PHVO) which result from partially oil hardening.
TFA also occur naturally in ruminant fat (meat, milk and their products). Epidemiologic studies suggest that not all TFA have the same negative effects on the cardiovascular system.
As the detrimental effect of TFA from PHVO is unquestioned (Mozaffarian et al. 2006, Ascherio et al. 1999), TFA from ruminant origin may have a neutral or positive effect on the cardiovascular system (Pfeuffer und Schrezenmeir 2006, Willett et al. 1993). The main reason is attributed to the different concentrations of TFA-isomers in the fat depending on the origin. Partially hydrogenated vegetable oils contains a high amount of elaidic acids (trans-9 18:1 isomer) and trans-10 18:1 isomers. Ruminant fats contain a high amount of vaccenic acids (trans-11 18:1 isomer). The vaccenic acid can be converted to the harmless conjugated linoleic acid (CLA) in the human and ruminant metabolic system.
TFA from PHVO have a negative effect on blood lipids and markers of the inflammatory system. They increase the Low Density Lipoproteins (LDL) and decrease the High Density Lipoproteins (HDL). Markers of the inflammatory system as TNFa Receptors, IL-6 and CRP increase with TFA consumption (Mensink et al. 2003; Mozaffarian 2006; Mozaffarian et al. 2009).
The discussion on the effect of TFA on insulin sensitivity is discussed conversely since there exists few studies which show different results. The trend indicates an impairment of insulin sensitivity with TFA consumption, particularly in predisposed persons (Hu 2001; Mozaffarian 2009; Risérus 2006).
Other studies indicated a negative effect on vessels' endothelial function and increase the level of soluble adhesion molecules (ICAM, VCAM) which are markers of endothelial dysfunction (Mozaffarian 2006; Mozaffarian et al. 2006).
Almost every typical risk factors of cardiovascular diseases induce changes in endothelial function which can preclinically be detected.
The analysis of endothelial function using endothelium-dependent flow-mediated dilation (FMD)and endothelium-independent vasodilation with nitroglycerin (NMD) of the brachial artery is a valuable, non-invasive method to determine the influence of various factors on the endothelial function (Moens et al. 2005).
Since changes in periphery are consistent with changes in the coronary vessels (Anderson et al. 1995), FMD represent a valuable indicator for cardiac events (Gokce et al. 2002, 2003; Widlansky et al. 2003). FMD is defined as percentage increase in vessel diameter from baseline conditions to maximum vessel diameter during hyperaemia (de Roos et al. 2003a).
Previous comparisons between TFA from ruminants and PHVO in clinical studies were only focused on changes in blood lipids (Chardigny et al. 2008, Motard-Bélanger et al. 2008).
Blood lipids are important factors concerning the risk of cardiovascular diseases, but not the only one as epidemiological and clinical studies indicated.
Studies on the effect of TFA on endothelial function, as well as on inflammatory and coagulation markers in the blood, become more important.
Objective:
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).
Methods:
Randomized, controlled, double blind study with healthy volunteers of both sex, aged between 45-65y. About 200 volunteers will be enrolled and randomized into 3 parallel study arms after a run-in period of 2 weeks.
Group 1 will follow a diet with 2% TFA of the total energy consumption from ruminant source, group 2 a diet with 2E% TFA from PHVO and group 3 a diet without any TFA for 4 weeks.
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 analyse blood lipids, inflammation and coagulation parameters in the blood. Nutrition councils will be passed at the beginning of the run-in period and then every 2 weeks. In the weeks between, the volunteers are contacted by phone.
- Conditions
- Healthy
- Being tested
- diet enriched with industrial trans fatty acids, diet enriched with ruminant trans fatty acids, diet without any trans fatty acids
- 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
- Medical subject headings
- Coronary Disease, Inflammation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet enriched with industrial trans fatty acidsDietary 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.
diet enriched with ruminant trans fatty acidsDietary 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.
diet without any trans fatty acidsDietary supplement
6 weeks with margarine without any trans fatty acids.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: diet without any trans fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function using flow-mediated dilation
Measured: 3 time points over 6 weeks (after 0, 2, 6 weeks)
Secondary outcomes (5)
inflammation parameters in blood samples
Measured: 6 weeks
coagulation parameters in blood samples
Measured: 6 weeks
blood lipids in blood samples
Measured: 6 weeks
adhesion molecules in blood samples
Measured: 6 weeks
insulin resistance via blood samples
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP, University of Bern, Schweizerische Herzstiftung, Bundesamt für Landwirtschaft, Emmi Schweiz AG
- Investigators
- Hugo Saner, Prof. Dr. med, Study director, Cardiovascular Prevention and Rehabilitation, University Hospital Bern, SwitzerlandAlexandra Schmid, Dipl. oec. troph., Study director, Agroscope Liebefeld-Posieux Research Station ALP, Posieux, SwitzerlandThomas Radtke, MSc, Principal investigator, Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933322
- Sponsor's protocol ID
- KEK 124/09
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2009
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 16611951Ascherio 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.
PubMed 10379026Willett 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 8094827Moens 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.
PubMed 15947345Mozaffarian 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.
PubMed 19424218Chardigny 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 18326592Motard-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 18326596Guggisberg 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.
PubMed 35982449Radtke 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.
PubMed 27899529
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans
- ClinicalTrials.gov ID
- NCT00933322
- Acronym / sponsor ID
- KEK 124/09
- Conditions
- Healthy
- Keywords
- ruminant, industrial, endothelial function, flow-mediated dilation, blood lipids, nutrition, trans fatty acids, coronary disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP, University of Bern, Schweizerische Herzstiftung, Bundesamt für Landwirtschaft, Emmi Schweiz AG
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Diet enriched with ruminant TFA has not a more negative effect on cardiovascular risk markers as diet without TFA.
Detailed description
Background:
For some time already negative effects of trans fatty acids (TFA) on the cardiovascular system are known. The main TFA sources in our nutrition are partly hydrogenated vegetable oils (PHVO) which result from partially oil hardening.
TFA also occur naturally in ruminant fat (meat, milk and their products). Epidemiologic studies suggest that not all TFA have the same negative effects on the cardiovascular system.
As the detrimental effect of TFA from PHVO is unquestioned (Mozaffarian et al. 2006, Ascherio et al. 1999), TFA from ruminant origin may have a neutral or positive effect on the cardiovascular system (Pfeuffer und Schrezenmeir 2006, Willett et al. 1993). The main reason is attributed to the different concentrations of TFA-isomers in the fat depending on the origin. Partially hydrogenated vegetable oils contains a high amount of elaidic acids (trans-9 18:1 isomer) and trans-10 18:1 isomers. Ruminant fats contain a high amount of vaccenic acids (trans-11 18:1 isomer). The vaccenic acid can be converted to the harmless conjugated linoleic acid (CLA) in the human and ruminant metabolic system.
TFA from PHVO have a negative effect on blood lipids and markers of the inflammatory system. They increase the Low Density Lipoproteins (LDL) and decrease the High Density Lipoproteins (HDL). Markers of the inflammatory system as TNFa Receptors, IL-6 and CRP increase with TFA consumption (Mensink et al. 2003; Mozaffarian 2006; Mozaffarian et al. 2009).
The discussion on the effect of TFA on insulin sensitivity is discussed conversely since there exists few studies which show different results. The trend indicates an impairment of insulin sensitivity with TFA consumption, particularly in predisposed persons (Hu 2001; Mozaffarian 2009; Risérus 2006).
Other studies indicated a negative effect on vessels' endothelial function and increase the level of soluble adhesion molecules (ICAM, VCAM) which are markers of endothelial dysfunction (Mozaffarian 2006; Mozaffarian et al. 2006).
Almost every typical risk factors of cardiovascular diseases induce changes in endothelial function which can preclinically be detected.
The analysis of endothelial function using endothelium-dependent flow-mediated dilation (FMD)and endothelium-independent vasodilation with nitroglycerin (NMD) of the brachial artery is a valuable, non-invasive method to determine the influence of various factors on the endothelial function (Moens et al. 2005).
Since changes in periphery are consistent with changes in the coronary vessels (Anderson et al. 1995), FMD represent a valuable indicator for cardiac events (Gokce et al. 2002, 2003; Widlansky et al. 2003). FMD is defined as percentage increase in vessel diameter from baseline conditions to maximum vessel diameter during hyperaemia (de Roos et al. 2003a).
Previous comparisons between TFA from ruminants and PHVO in clinical studies were only focused on changes in blood lipids (Chardigny et al. 2008, Motard-Bélanger et al. 2008).
Blood lipids are important factors concerning the risk of cardiovascular diseases, but not the only one as epidemiological and clinical studies indicated.
Studies on the effect of TFA on endothelial function, as well as on inflammatory and coagulation markers in the blood, become more important.
Objective:
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).
Methods:
Randomized, controlled, double blind study with healthy volunteers of both sex, aged between 45-65y. About 200 volunteers will be enrolled and randomized into 3 parallel study arms after a run-in period of 2 weeks.
Group 1 will follow a diet with 2% TFA of the total energy consumption from ruminant source, group 2 a diet with 2E% TFA from PHVO and group 3 a diet without any TFA for 4 weeks.
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 analyse blood lipids, inflammation and coagulation parameters in the blood. Nutrition councils will be passed at the beginning of the run-in period and then every 2 weeks. In the weeks between, the volunteers are contacted by phone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ruminant TFA | Active comparator | Dietary Supplement: diet enriched with ruminant trans fatty acidsIn 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. |
| industrial TFA | Active comparator | Dietary Supplement: diet enriched with industrial trans fatty acidsIn 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. |
| without TFA | Placebo comparator | Dietary Supplement: diet without any trans fatty acidsIn 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. |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 45-69
- body mass index 20-30 kg/m2
- willingness to hold physical activity constant over study duration
- written informed consent
Key exclusion criteria (15 listed)
- smoking
- hypertension (> 140/90 mm Hg)
- hypotension (men < 115 mm Hg; women < 105 mm Hg)
- obesity (BMI =/> 30 kg/m2)
- vegan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet enriched with industrial trans fatty acidsAfter 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. | Dietary supplement | industrial TFA |
| diet enriched with ruminant trans fatty acidsAfter 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. | Dietary supplement | ruminant TFA |
| diet without any trans fatty acids6 weeks with margarine without any trans fatty acids. | Dietary supplement | without TFA |
Primary outcome
endothelial function using flow-mediated dilation
Time frame: 3 time points over 6 weeks (after 0, 2, 6 weeks)
5 secondary outcomes
inflammation parameters in blood samples
Time frame: 6 weeks
coagulation parameters in blood samples
Time frame: 6 weeks
blood lipids in blood samples
Time frame: 6 weeks
adhesion molecules in blood samples
Time frame: 6 weeks
insulin resistance via blood samples
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- Background: PubMed 16611951Mozaffarian 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.
- Background: PubMed 10379026Ascherio 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.
- Background: PubMed 8094827Willett 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.
- Background: PubMed 15947345Moens 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.
- Results publication: PubMed 19424218Mozaffarian 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.
- Results publication: PubMed 18326592Chardigny 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.
- Results publication: PubMed 18326596Motard-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.
- Derived from this study: PubMed 35982449Guggisberg 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.
- Derived from this study: PubMed 27899529Radtke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Saner, Prof. Dr. med study director
Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland
Alexandra Schmid, Dipl. oec. troph. study director
Agroscope Liebefeld-Posieux Research Station ALP, Posieux, Switzerland
Thomas Radtke, MSc principal investigator
Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet enriched with industrial trans fatty acids, diet enriched with ruminant trans fatty acids and diet without any trans fatty acids in people with Healthy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 12 Jul 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Recruitment problems). Results are not available in the source record.
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?
endothelial function using flow-mediated dilation (time frame: 3 time points over 6 weeks (after 0, 2, 6 weeks)). 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 NCT00933322, which also lists 9 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 12 Jul 2013.