Cardiovascular DiseaseNCT00942656
Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease
A study testing PHVO, CLA and VA in people with Cardiovascular Disease, run by United States Department of Agriculture (USDA) at 1 site in United States.
Trial summary
The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- PHVO, CLA and VA
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 20 and 38 kg/m2
- Age 25 to 65 years during the intervention
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 mm Hg (controlled with certain medications)
- Total plasma cholesterol < 280 mg/dl
- Fasting triglycerides < 300 mg/dl
Who cannot join
- Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
- History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
- Women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.
- Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study.
Show all 13Show fewer
- Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months.
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
- Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
- Smokers or other tobacco users (during the 6 months prior to the start of the study).
- Unable or unwilling to give informed consent or communicate with study staff.
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion).
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11 conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL cholesterol compared to a low trans fatty acid diet.
- Conditions
- Cardiovascular Disease
- Being tested
- PHVO, CLA, VA, base
- Keywords
- trans fatty acids, ruminant, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHVOOther
base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil
CLAOther
base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid
VAOther
base diet plus 3.0% energy added from vaccenic acid
baseOther
base diet containing approximately 0.1% energy of mixed trans fatty acid isomers
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009
- Study completionSep 2009
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Investigators
- David J Baer, Ph. D., Principal investigator, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942656
- Sponsor's protocol ID
- 2006-293
- Status last verified
- Feb 2011
- First submitted
- 17 Jul 2009
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gebauer SK, Destaillats F, Dionisi F, Krauss RM, Baer DJ. Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1339-46. doi: 10.3945/ajcn.115.116129. Epub 2015 Nov 11.
PubMed 26561632
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trans Fatty Acids From Ruminant Sources on Risk Factors for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00942656
- Acronym / sponsor ID
- 2006-293
- Conditions
- Cardiovascular Disease
- Keywords
- trans fatty acids, ruminant, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 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 objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11 conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL cholesterol compared to a low trans fatty acid diet.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI between 20 and 38 kg/m2
- Age 25 to 65 years during the intervention
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 mm Hg (controlled with certain medications)
- Total plasma cholesterol < 280 mg/dl
Key exclusion criteria (13 listed)
- Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
- History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
- Women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women.
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 |
|---|---|---|
| PHVObase diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil | Other | – |
| CLAbase diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid | Other | – |
| VAbase diet plus 3.0% energy added from vaccenic acid | Other | – |
| basebase diet containing approximately 0.1% energy of mixed trans fatty acid isomers | Other | – |
Primary outcome
LDL cholesterol
Time frame: 4 weeks
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 9 Feb 2011.
- Derived from this study: PubMed 26561632Gebauer SK, Destaillats F, Dionisi F, Krauss RM, Baer DJ. Vaccenic acid and trans fatty acid isomers from partially hydrogenated oil both adversely affect LDL cholesterol: a double-blind, randomized controlled trial. Am J Clin Nutr. 2015 Dec;102(6):1339-46. doi: 10.3945/ajcn.115.116129. Epub 2015 Nov 11.
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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.
David J Baer, Ph. D. principal investigator
United States Department of Agriculture (USDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHVO, CLA and VA in people with Cardiovascular Disease, run by United States Department of Agriculture (USDA) at 1 site in United States.
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 6 inclusion and 13 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 9 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 United States. 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?
LDL cholesterol (time frame: 4 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 NCT00942656, 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 9 Feb 2011; AzTrials last refreshed its copy on 6 Nov 2026.