Insulin ResistanceTrans-InsulinNCT00617435
Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development
A study testing vaccenic acid enriched diet and Elaidic acid enriched diet in people with Insulin Resistance and Obesity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 2 sites in France.
Trial summary
The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- vaccenic acid enriched diet and Elaidic acid enriched diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2007to Jan 2009
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female
- waist measurement > 88 cm
- body mass index> 28kg/m2
- Affiliated to National Health Insurance
- Subject giving his/her written informed consent
- Subject willing to comply with the study procedures
- Subject considered as normal after clinical examination and medical questionnaire
Who cannot join
- Reported food allergies
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- Hepatic or renal impairments
- Positive serologies to HIV or HCV, determined on blood sample
- pregnant or presently attempting to get pregnant or menopause or lactating Blood donation done less than 2 months before the start of the study
- Chronic pathologies: diabetes, hypertriglyceridemia, hypertension, cardiovascular diseases, chronic inflammatory diseases
Show all 20Show fewer
- Intestine, cardiovascular, kidney and cancer pathologies in the last 5 years
- Previous heavy intestine surgery (except appendicectomy)
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- High variation (> 5%) of body weight during the last 3 months
- Consuming nutritional supplements which could interfered with lipid metabolism (fish oil capsule, vitamins, soja lecithins,…)
- Heavy consumer of alcohol
- Smoker or ex-smoker who stopped smoking less than 1 month before V0 (more than 5 cigarettes/dy).
- Practising intensive physical exercise (> 5 h per week)
- Vegetarian or vegan
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Disliking butter, margarine, cheese, biscuits and/or vegetable oil
- Dietary habits unreliable to controlled food intake
- Being in exclusion on the National Volunteers Data file
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Recherche en Nutrition Humaine Auvergne
Clermont-Ferrand, 63000
Centre de Recherche en Nutrition Humaine Rhônes-Alpes
Lyon, 69000
About this study
The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.
Read the detailed description
Women will be included in the study according to their susceptibility to develop a insulin resistance (evaluated starting from the body index of mass IMC superior to 28 kg.m-², of the waist measurement 88 cm). Once included in the study, the volunteers will receive for 4 weeks butter, dairy products and biscuits enriched in stearic, elaidic or vaccenic acid. The volunteers will undergo a measurement of the body composition by biphotonic absorptiometry as well as a complete metabolic assessment (blood and urinary samples, clamp to insulin and biopsies).
- Conditions
- Insulin Resistance, Obesity
- Being tested
- vaccenic acid enriched diet, Elaidic acid enriched diet, control diet
- Keywords
- Trans fatty acid, Insulin resistance, Skeletal muscle, Adipose tissue
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccenic acid enriched dietDietary supplement
The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil.
Elaidic acid enriched dietDietary supplement
Mixture of vegetable oils (including partially hydrogenated oils)
control dietDietary supplement
Mixed of different oil
| Study group | Role | What they receive |
|---|---|---|
| V | Experimental | Not described Receives: Dietary Supplement: vaccenic acid enriched diet |
| N | Experimental | Not described Receives: Dietary Supplement: Elaidic acid enriched diet |
| J | Experimental | Not described Receives: Dietary Supplement: control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.
Measured: before and after 4 weeks of diets.
Secondary outcomes (1)
Muscle and adipose tissue biopsies and Body composition
Measured: before and after 4 weeks of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, MD, PU-PH, Principal investigator, UMR1019 INRA - Université Clermont1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617435
- Sponsor's protocol ID
- 2006-A00397-44
- Other IDs
- AU679, 2006-0132
- Acronym
- Trans-Insulin
- Status last verified
- Mar 2009
- First submitted
- 5 Feb 2008
- Last updated
- 24 Nov 2025
- Results posted
- No
Publications
Chardigny JM, Malpuech-Brugere C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sebedio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. doi: 10.1016/j.cct.2006.03.003. Epub 2006 Apr 24.
PubMed 16632411Tardy AL, Lambert-Porcheron S, Malpuech-Brugere C, Giraudet C, Rigaudiere JP, Laillet B, Leruyet P, Peyraud JL, Boirie Y, Laville M, Michalski MC, Chardigny JM, Morio B. Dairy and industrial sources of trans fat do not impair peripheral insulin sensitivity in overweight women. Am J Clin Nutr. 2009 Jul;90(1):88-94. doi: 10.3945/ajcn.2009.27515. Epub 2009 May 27.
PubMed 19474135
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Trans Fatty Acids From Natural and Industrial Origin in the Induction of Insulin Resistance Development
- ClinicalTrials.gov ID
- NCT00617435
- Acronym / sponsor ID
- Trans-Insulin / 2006-A00397-44
- Conditions
- Insulin Resistance, Obesity
- Keywords
- Trans fatty acid, Insulin resistance, Skeletal muscle, Adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Feb 2008 (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 investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.
Detailed description
Women will be included in the study according to their susceptibility to develop a insulin resistance (evaluated starting from the body index of mass IMC superior to 28 kg.m-², of the waist measurement 88 cm). Once included in the study, the volunteers will receive for 4 weeks butter, dairy products and biscuits enriched in stearic, elaidic or vaccenic acid. The volunteers will undergo a measurement of the body composition by biphotonic absorptiometry as well as a complete metabolic assessment (blood and urinary samples, clamp to insulin and biopsies).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V | Experimental | Dietary Supplement: vaccenic acid enriched diet |
| N | Experimental | Dietary Supplement: Elaidic acid enriched diet |
| J | Experimental | Dietary Supplement: control diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female
- waist measurement > 88 cm
- body mass index> 28kg/m2
- Affiliated to National Health Insurance
- Subject giving his/her written informed consent
Key exclusion criteria (20 listed)
- Reported food allergies
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- Hepatic or renal impairments
- Positive serologies to HIV or HCV, determined on blood sample
- pregnant or presently attempting to get pregnant or menopause or lactating Blood donation done less than 2 months before the start of the study
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 |
|---|---|---|
| vaccenic acid enriched dietThe experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil. | Dietary supplement | V |
| Elaidic acid enriched dietMixture of vegetable oils (including partially hydrogenated oils) | Dietary supplement | N |
| control dietMixed of different oil | Dietary supplement | J |
Primary outcome
Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp.
Time frame: before and after 4 weeks of diets.
1 secondary outcome
Muscle and adipose tissue biopsies and Body composition
Time frame: before and after 4 weeks of diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 16632411Chardigny JM, Malpuech-Brugere C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sebedio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. doi: 10.1016/j.cct.2006.03.003. Epub 2006 Apr 24.
- Derived from this study: PubMed 19474135Tardy AL, Lambert-Porcheron S, Malpuech-Brugere C, Giraudet C, Rigaudiere JP, Laillet B, Leruyet P, Peyraud JL, Boirie Y, Laville M, Michalski MC, Chardigny JM, Morio B. Dairy and industrial sources of trans fat do not impair peripheral insulin sensitivity in overweight women. Am J Clin Nutr. 2009 Jul;90(1):88-94. doi: 10.3945/ajcn.2009.27515. Epub 2009 May 27.
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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.
Yves Boirie, MD, PU-PH principal investigator
UMR1019 INRA - Université Clermont1
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaccenic acid enriched diet and Elaidic acid enriched diet in people with Insulin Resistance and Obesity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 2 sites in France.
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 7 inclusion and 20 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Measure of insulin sensitivity by an hyperinsulinemic- euglycemic clamp. (time frame: before and after 4 weeks of 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 NCT00617435, which also lists 2 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 24 Nov 2025.