Cardiovascular DiseaseTRANSNCT01163175
Study of the Impact of Trans Fatty Acids From Dairy Products on Cardiovascular Risk Factors
A study testing Ruminant trans fats in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
Trial summary
The majority of trans fatty acids consumed by the general population is derived from products that have been formulated using significant amount of hydrogenated vegetable oil (the so-called industrial trans fat). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Ruminant trans fats
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Nov 2007
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- LDL-Cholesterol concentration <3.4 mmol/L
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Who cannot join
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Body mass index > 30 kg/m2
- Food allergies
- Men with extreme nutritional habits such as vegetarism or alcohol consumption > 2 drinks/day
- Elite athletes
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Québec, Quebec, G1V 0A6
About this study
Official title: Study of the Impact of Trans Fatty Acids From Dairy Products n Cardiovascular Risk Factors
The majority of trans fatty acids consumed by the general population is derived from products that have been formulated using significant amount of hydrogenated vegetable oil (the so-called industrial trans fat). Fat from ruminants also contains small amounts of trans fatty acid, which contribute, although to a smaller extent, to the total dietary intake of trans fatty acids in the general population. The negative impact of consuming industrial trans fat on health, particularly on cardiovascular disease, is being increasingly recognized. Based on data available to date, it is currently not possible to conclude if effects of ruminants and industrial trans fatty acid on cardiovascular risk are different. There is therefore an urgent need for a study that compares the impact of naturally occurring trans fatty acids such as those from dairy products and of trans fatty acids form industrial sources on cardiovascular risk factors as well as their mechanisms of action.
The general objective of the study is to investigate the impact of naturally occurring trans fatty acids from dairy products (mainly vaccenic acid) on plasma cholesterol levels and other risk factors for cardiovascular disease.
Read the detailed description
The proposed research will be undertaken as a double-blind randomized cross-over study according to a Latin Square design, with participants being subjected to 4 consecutive isocaloric diets in random order lasting 4 weeks each. No stratification is considered since the population recruited will be relatively homogeneous. The 4 experimental diets are: 1- a diet rich in ruminant TFA (8 g/day); 2- a diet moderately rich in ruminant TFA (4 g/day); 3- a diet rich in industrial TFA (8 g/d); 4- a control diet (minimal dietary TFA of industrial and ruminant sources). The source of ruminant TFA will come from butter and cream obtained after having modified the regimen of lactating cows in a fashion similar to the one used to increase the levels of conjugated linoleic acid (CLA) in milk fat. Hydrogenated margarine will be used as the main source of industrial TFA. Finally, a butter obtained from cows producing the lowest levels of ruminant fat will be used to formulate the control diet (minimal dietary TFA). All diets will be identical in terms of menus, calories and macronutrient composition with the exception of TFA sources and levels. Minor differences in the levels of total saturated, monounsaturated and polyunsaturated fatty acids will be matched across diets by adding various vegetable and animal oils. The macronutrient composition of each meal and thus of the entire day is very similar across all 4 diets. Based on a 2500 kcal/day regimen, an intake of TFA of 8 g/d and 4 g/d will represent 72 kcal/day and 36 kcal/day respectively (3% and 1.5% of energy intake). The 4 experimental diets will be formulated so that the percentage of daily calories from fat (36%), carbohydrates (50%) and proteins (14%) will meet most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of SAT (slight excess) and fibers (slight deficit). The slight excess in SAT fat cannot be avoided since we are using butter as the primary source of ruminant TFA. The cholesterol content of the experimental diet will not exceed 300 mg/day.
- Conditions
- Cardiovascular Disease
- Being tested
- Ruminant trans fats
- Keywords
- Cardiovascular disease, Trans fatty acids, Ruminant, Blood lipids
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruminant trans fatsOther
Consumption of the 4 experimental diets:
- a diet rich in ruminant TFA (8 g/day);
- a diet moderately rich in ruminant TFA (4 g/day);
- a diet rich in industrial TFA (8 g/d);
- a control diet (minimal dietary TFA of industrial and ruminant sources).
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma LDL-Cholesterol concentrations
Measured: At the beginning and the end of the 4 for-week diets
Secondary outcomes (5)
Blood lipids and apolipoproteins levels (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B)
Measured: At the beginning and the end of the 4 for-week diets
Markers of inflammation (C-reactive protein)
Measured: At the beginning and the end of the 4 for-week diets
Blood pressure
Measured: At the beginning and the end of the 4 for-week diets
Anthropometric measures (waist and hip circumferences)
Measured: At the beginning and the end of the 4 for-week diets
Surrogates of cholesterol absorption and synthesis
Measured: At the beginning and the end of the 4 for-week diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada, Novalait Inc
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163175
- Sponsor's protocol ID
- INAF-2005-233
- Acronym
- TRANS
- Status last verified
- Jul 2010
- First submitted
- 9 Jul 2010
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Trans Fatty Acids From Dairy Products n Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT01163175
- Acronym / sponsor ID
- TRANS / INAF-2005-233
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular disease, Trans fatty acids, Ruminant, Blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada, Novalait Inc
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Jul 2010 (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 majority of trans fatty acids consumed by the general population is derived from products that have been formulated using significant amount of hydrogenated vegetable oil (the so-called industrial trans fat). Fat from ruminants also contains small amounts of trans fatty acid, which contribute, although to a smaller extent, to the total dietary intake of trans fatty acids in the general population. The negative impact of consuming industrial trans fat on health, particularly on cardiovascular disease, is being increasingly recognized. Based on data available to date, it is currently not possible to conclude if effects of ruminants and industrial trans fatty acid on cardiovascular risk are different. There is therefore an urgent need for a study that compares the impact of naturally occurring trans fatty acids such as those from dairy products and of trans fatty acids form industrial sources on cardiovascular risk factors as well as their mechanisms of action.
The general objective of the study is to investigate the impact of naturally occurring trans fatty acids from dairy products (mainly vaccenic acid) on plasma cholesterol levels and other risk factors for cardiovascular disease.
Detailed description
The proposed research will be undertaken as a double-blind randomized cross-over study according to a Latin Square design, with participants being subjected to 4 consecutive isocaloric diets in random order lasting 4 weeks each. No stratification is considered since the population recruited will be relatively homogeneous. The 4 experimental diets are: 1- a diet rich in ruminant TFA (8 g/day); 2- a diet moderately rich in ruminant TFA (4 g/day); 3- a diet rich in industrial TFA (8 g/d); 4- a control diet (minimal dietary TFA of industrial and ruminant sources). The source of ruminant TFA will come from butter and cream obtained after having modified the regimen of lactating cows in a fashion similar to the one used to increase the levels of conjugated linoleic acid (CLA) in milk fat. Hydrogenated margarine will be used as the main source of industrial TFA. Finally, a butter obtained from cows producing the lowest levels of ruminant fat will be used to formulate the control diet (minimal dietary TFA). All diets will be identical in terms of menus, calories and macronutrient composition with the exception of TFA sources and levels. Minor differences in the levels of total saturated, monounsaturated and polyunsaturated fatty acids will be matched across diets by adding various vegetable and animal oils. The macronutrient composition of each meal and thus of the entire day is very similar across all 4 diets. Based on a 2500 kcal/day regimen, an intake of TFA of 8 g/d and 4 g/d will represent 72 kcal/day and 36 kcal/day respectively (3% and 1.5% of energy intake). The 4 experimental diets will be formulated so that the percentage of daily calories from fat (36%), carbohydrates (50%) and proteins (14%) will meet most of the dietary recommendations of the American Heart Association and the NCEP for primary prevention of CVD, with the exception of SAT (slight excess) and fibers (slight deficit). The slight excess in SAT fat cannot be avoided since we are using butter as the primary source of ruminant TFA. The cholesterol content of the experimental diet will not exceed 300 mg/day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men
- LDL-Cholesterol concentration <3.4 mmol/L
- Stable body weight (+/- 2 kg) for 6 months before the beginning of the study
- Smoking or not
Key exclusion criteria (7 listed)
- Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
- Subjects taking medications for hyperlipidemia or hypertension
- Endocrine disorders
- Body mass index > 30 kg/m2
- Food allergies
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 |
|---|---|---|
| Ruminant trans fatsConsumption of the 4 experimental diets: 1. a diet rich in ruminant TFA (8 g/day); 2. a diet moderately rich in ruminant TFA (4 g/day); 3. a diet rich in industrial TFA (8 g/d); 4. a control diet (minimal dietary TFA of industrial and ruminant sources). | Other | – |
Primary outcome
Plasma LDL-Cholesterol concentrations
Time frame: At the beginning and the end of the 4 for-week diets
5 secondary outcomes
Blood lipids and apolipoproteins levels (Total cholesterol, HDL-Cholesterol, Triglycerides, Apo A1, Apo B)
Time frame: At the beginning and the end of the 4 for-week diets
Markers of inflammation (C-reactive protein)
Time frame: At the beginning and the end of the 4 for-week diets
Blood pressure
Time frame: At the beginning and the end of the 4 for-week diets
Anthropometric measures (waist and hip circumferences)
Time frame: At the beginning and the end of the 4 for-week diets
Surrogates of cholesterol absorption and synthesis
Time frame: At the beginning and the end of the 4 for-week 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 11 Feb 2011.
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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.
Benoît Lamarche, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruminant trans fats in people with Cardiovascular Disease, run by Laval University at 1 site in Canada.
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 7 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 11 Feb 2011. 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 Canada. 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?
Plasma LDL-Cholesterol concentrations (time frame: At the beginning and the end of the 4 for-week diets). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2011.