Trial record 1 of 246 for:
Open Studies | "Fatty Acids"
Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans
This study is currently recruiting participants.
Verified January 2013 by University Hospital Inselspital, Berne
Sponsor:
University Hospital Inselspital, Berne
Collaborators:
Agroscope Liebefeld-Posieux Research Station ALP
CTU Bern, Clinical Trials Unit, Bern
Schweizerische Herzstiftung
Bundesamt für Landwirtschaft
Emmi Schweiz AG
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00933322
First received: July 2, 2009
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: diet enriched with industrial trans fatty acids Dietary Supplement: diet enriched with ruminant trans fatty acids Dietary Supplement: diet without any trans fatty acids |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Randomized-controlled Trial to Assess the Effects of Different Trans-fatty Acids on Endothelial Function in Humans |
Resource links provided by NLM:
Further study details as provided by University Hospital Inselspital, Berne:
Primary Outcome Measures:
- endothelial function using flow-mediated dilation [ Time Frame: 3 time points over 6 weeks (after 0, 2, 6 weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- inflammation parameters in blood samples [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- coagulation parameters in blood samples [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- blood lipids in blood samples [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- adhesion molecules in blood samples [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- insulin resistance via blood samples [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 205 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ruminant TFA
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
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.
|
|
Active Comparator: industrial TFA
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
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.
|
|
Placebo Comparator: without TFA
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
6 weeks with margarine without any trans fatty acids.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- age 45-69
- body mass index 20-30 kg/m2
- willingness to hold physical activity constant over study duration
- written informed consent
Exclusion Criteria
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933322
Contacts
| Contact: Thomas Radtke, MSc | +41 31 632 79 11 | thomas.radtke@insel.ch |
| Contact: Hugo Saner, Prof. Dr. med. | +41 031 632 89 86 | hugo.saner@insel.ch |
Locations
| Switzerland | |
| Cardiovascular Prevention and Rehabilitation, Bern University Hospital | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Thomas Radtke, MSc +41 31 632 79 11 thomas.radtke@insel.ch | |
| Contact: Hugo Saner, Prof. Dr. med. +41 031 632 89 86 hugo.saner@insel.ch | |
| Principal Investigator: Thomas Radtke, MSc | |
Sponsors and Collaborators
University Hospital Inselspital, Berne
Agroscope Liebefeld-Posieux Research Station ALP
CTU Bern, Clinical Trials Unit, Bern
Schweizerische Herzstiftung
Bundesamt für Landwirtschaft
Emmi Schweiz AG
Investigators
| Study Director: | 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 |
| Principal Investigator: | Thomas Radtke, MSc | Cardiovascular Prevention and Rehabilitation, University Hospital Bern, Switzerland |
More Information
Publications:
| Responsible Party: | Hugo Saner/ Prof. Dr. med, Bern University Hospital |
| ClinicalTrials.gov Identifier: | NCT00933322 History of Changes |
| Other Study ID Numbers: | KEK 124/09 |
| Study First Received: | July 2, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital Inselspital, Berne:
|
trans fatty acids ruminant industrial endothelial function flow-mediated dilation blood lipids |
nutrition coronary disease endothelial function of the brachial artery inflammation insulin resistancy coagulation |
ClinicalTrials.gov processed this record on May 22, 2013