Cardiovascular DiseaseTRANSFACT1NCT00439582
Trans Fatty Acids and Cardiovascular Risk Factors
A study testing vaccenic acid enriched milk fat (VAMF) [Transfact1] and hydrogenated oil in people with Cardiovascular Disease, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
Background: Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- vaccenic acid enriched milk fat (VAMF) [Transfact1] and hydrogenated oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2005to Dec 2005
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HDL cholesterol, g/L > 0.4
- Triacylglycerol g/L <1.50
- LDL Cholesterol g/L <1.60
- Affiliated to National Health Insurance
- Waist size < 102 cm (men) or 88 cm (women)
- Normal blood pressure (diastolic <90 mm Hg, systolic <140 mm Hg)
Show all 12Show fewer
- Normal liver functions (γ-GT, transaminases, alkaline phosphatase)
- Normal white blood cells count (4-10 g/L)
- For women: effective contraception
- 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
- For women, pregnant or presently attempting to get pregnant (-HCG blood test) or menopause or lactating
- Blood donation done less than 2 months before the start of the study
Show all 22Show fewer
- Chronic pathologies: diabetes (fasted glycaemia > 6,1 mmol/L), hypertriglyceridemia (≥1.50 g/L), hypertension (systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg), cardiovascular diseases, chronic inflammatory diseases
- 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 (evaluated thanks to the values of the following hepatic enzymes: -GT, ASAT, ALAT)
- Smoker or ex-smoker who stopped smoking less than 1 month before V0
- Practicing intensive physical exercise (> 3 h per week)
- Vegetarian or vegan
- Taking medication for depressive or psychiatric state
- 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
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Clermont-Ferrand, 63009
About this study
Official title: Comparative Effect of 2 Different Sources of Trans Fatty Acid (Milk Fat vs Hydrogenated Oil)on Cardiovascular Risk Factors in Healthy Humans
Background:
Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects.
Read more
Methodology:
To compare the effects of industrial and natural dietary sources of TFA, two specific test fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in TFA has been produced by modification of the cow's diet and selection of cows with the highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily energy (based on 2000 kcal/day). These two test fats have been incorporated into food items and will be provided to 46 healthy subjects under a randomised, double blind, controlled, cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated.
Read the detailed description
Design:
This is a double blind, controlled, randomised, cross-over, single center clinical trial.
Product(s) to be tested:
Food items (butter, cheese and biscuits) manufactured using (i) an experimental milk fat and (ii) a mixture of vegetable oils (including partially hydrogenated oils), used as control. Both fats are balanced for their trans fatty acid content and saturated fatty acids content. The main difference of these two experimental fats (milk fat and control fat) is the distribution of trans fatty acids (TFA). The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil. The distribution (the quality) of monounsaturated C18:1 TFA in the VAMF is therefore close to the usual milk fat, but with higher levels (enriched milk).The experimental control fat, shorted CTRL, has been obtained by mixing partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats.
Amount, dosage, route of administration, duration of treatment:
During the 1-week run-in period, subjects should eat daily the same products as the experimental ones (butter, cheese and biscuits) but manufactured using usual milk collected in France. The subjects should then eat daily for 3 weeks butter, cheese and biscuits containing one of the 2 experimental fats (milk fat or control fat, cross-over with 1-week wash-out period) so that they eat daily about 54 g of the experimental fat, which contain about 20-22% of TFA. The total study duration for each subject is 8 weeks: 1-week run-in period, 3-week experimental fat diet in cross-over with 1-week wash-out period between both experimental periods.
All the measurements and blood samplings will be done on the first day of week 1, 3, 4, 5, 7 and 8.
Primary outcome:
HDL-Cholesterol (HDL-C) levels
Secondary outcomes:
- Triglycerides, total cholesterol, Apo A1 , Apo B, factor VII and factor VIIa, fibrinogen levels. Lp(a) and CETP, measured on plasma by fluorimetry. LDL-cholesterol (LDL-C) will be calculated
- LDL, HDL and VLDL levels and subclasses
Other outcome:
evaluation of the fatty acid profiles of plasma cholesteryl esters and phospholipids
- Conditions
- Cardiovascular Disease
- Being tested
- vaccenic acid enriched milk fat (VAMF) [Transfact1], hydrogenated oil
- Keywords
- Lipoproteins, Milk fat, Public health nutrition, trans fatty acid
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccenic acid enriched milk fat (VAMF) [Transfact1]Dietary supplement
hydrogenated oilDietary supplement
Partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: vaccenic acid enriched milk fat (VAMF) [Transfact1] |
| 2 | Experimental | Not described Receives: Dietary Supplement: hydrogenated oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-Cholesterol (HDL-C) levels.
Secondary outcomes (9)
Triglycerides
Total cholesterol
Apo A1
Apo B
Factor VII
Factor VIIa
fibrinogen levels
Lp(a)
LDL, HDL and VLDL levels and subclasses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startAug 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 46 participants
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 Clermont1Jean-Michel Chardigny, PhD, Study director, UMR 1019 INRA - Université Clermont1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439582
- Sponsor's protocol ID
- AU599
- Other IDs
- 04.28.NRC
- Acronym
- TRANSFACT1
- Status last verified
- Mar 2009
- First submitted
- 21 Feb 2007
- Last updated
- 21 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 16632411
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of 2 Different Sources of Trans Fatty Acid (Milk Fat vs Hydrogenated Oil)on Cardiovascular Risk Factors in Healthy Humans
- ClinicalTrials.gov ID
- NCT00439582
- Acronym / sponsor ID
- TRANSFACT1 / AU599
- Conditions
- Cardiovascular Disease
- Keywords
- Lipoproteins, Milk fat, Public health nutrition, trans fatty acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Dec 2005
- First posted
- 23 Feb 2007 (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.
Background:
Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented. However, very little information is available on the effect of natural sources of TFA coming from milk fat, dairy products and ruminant meat. In fact, due to the naturally low level of TFA in milk fat, it is almost impossible to conduct a clinical trial with a limited number of subjects.
Methodology:
To compare the effects of industrial and natural dietary sources of TFA, two specific test fats have been designed and produced. A substantial amount of milk fat (130 kg) enriched in TFA has been produced by modification of the cow's diet and selection of cows with the highest TFA content. The level obtained was approximately 4- to 7-fold higher than typically present in milk fat ( - 20 instead of 3-6 g/100 g of total fatty acids). The control fat is composed of PHVO balanced in saturated fatty acids (lauric, myristic and palmitic). Both experimental fats contain about 20-22% of monounsaturated TFA and the volunteers' daily experimental fat intake (54 g), will represent about 12.0 g/day of TFA or 5.4% of the daily energy (based on 2000 kcal/day). These two test fats have been incorporated into food items and will be provided to 46 healthy subjects under a randomised, double blind, controlled, cross-over design. The primary outcome is high-density lipoprotein cholesterol (HDL-C), which is an independent risk factor for CVD. Other parameters such as lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C), and HDL-C level and subclasses will be also to be evaluated.
Detailed description
Design:
This is a double blind, controlled, randomised, cross-over, single center clinical trial.
Product(s) to be tested:
Food items (butter, cheese and biscuits) manufactured using (i) an experimental milk fat and (ii) a mixture of vegetable oils (including partially hydrogenated oils), used as control. Both fats are balanced for their trans fatty acid content and saturated fatty acids content. The main difference of these two experimental fats (milk fat and control fat) is the distribution of trans fatty acids (TFA). The experimental milk fat, entitled "vaccenic acid enriched milk fat" (VAMF), has been obtained by feeding cows with a diet containing sunflower oil. The distribution (the quality) of monounsaturated C18:1 TFA in the VAMF is therefore close to the usual milk fat, but with higher levels (enriched milk).The experimental control fat, shorted CTRL, has been obtained by mixing partially hydrogenated vegetable oils (PHVO) and vegetable oils and fats.
Amount, dosage, route of administration, duration of treatment:
During the 1-week run-in period, subjects should eat daily the same products as the experimental ones (butter, cheese and biscuits) but manufactured using usual milk collected in France. The subjects should then eat daily for 3 weeks butter, cheese and biscuits containing one of the 2 experimental fats (milk fat or control fat, cross-over with 1-week wash-out period) so that they eat daily about 54 g of the experimental fat, which contain about 20-22% of TFA. The total study duration for each subject is 8 weeks: 1-week run-in period, 3-week experimental fat diet in cross-over with 1-week wash-out period between both experimental periods.
All the measurements and blood samplings will be done on the first day of week 1, 3, 4, 5, 7 and 8.
Primary outcome:
HDL-Cholesterol (HDL-C) levels
Secondary outcomes:
- Triglycerides, total cholesterol, Apo A1 , Apo B, factor VII and factor VIIa, fibrinogen levels. Lp(a) and CETP, measured on plasma by fluorimetry. LDL-cholesterol (LDL-C) will be calculated
- LDL, HDL and VLDL levels and subclasses
Other outcome:
evaluation of the fatty acid profiles of plasma cholesteryl esters and phospholipids
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: vaccenic acid enriched milk fat (VAMF) [Transfact1] |
| 2 | Experimental | Dietary Supplement: hydrogenated oil |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- HDL cholesterol, g/L > 0.4
- Triacylglycerol g/L <1.50
- LDL Cholesterol g/L <1.60
- Affiliated to National Health Insurance
- Waist size < 102 cm (men) or 88 cm (women)
Key exclusion criteria (22 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
- For women, pregnant or presently attempting to get pregnant (-HCG blood test) or menopause or lactating
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 milk fat (VAMF) [Transfact1] | Dietary supplement | 1 |
| hydrogenated oilPartially hydrogenated vegetable oils (PHVO) and vegetable oils and fats | Dietary supplement | 2 |
Primary outcome
HDL-Cholesterol (HDL-C) levels.
9 secondary outcomes
Triglycerides
Total cholesterol
Apo A1
Apo B
Factor VII
Factor VIIa
fibrinogen levels
Lp(a)
LDL, HDL and VLDL levels and subclasses
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 21 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.
Related trials for Cardiovascular Disease
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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
Jean-Michel Chardigny, PhD study director
UMR 1019 INRA - Université Clermont1
1 site 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 milk fat (VAMF) [Transfact1] and hydrogenated oil in people with Cardiovascular Disease, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site 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 12 inclusion and 22 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 21 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 1 site 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?
HDL-Cholesterol (HDL-C) levels.. 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 NCT00439582, which also lists 1 linked publication.
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 21 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.