HealthyCLARINeTNCT00529828
Health Effects of CLA Versus Industrial Trans Fatty Acids
A study testing Consumption of CLA enriched food in people with Healthy, run by Wageningen University at 1 site in Netherlands.
Trial summary
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Consumption of CLA enriched food
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Jan 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65 years
- healthy
Who cannot join
- serum total cholesterol >= 6,5 mmol/L
- serum triglycerides > 2,3 mmol/L
- chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- use of cholesterol lowering medication
- use of blood pressure lowering medication
- high alcohol intake
Show all 9Show fewer
- BMI > 30
- pregnant and lactation women
- unusual dietary requirements
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, 6703 HD
About this study
Official title: Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.
The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.
Read the detailed description
It will be a double-blind randomized multiple cross-over trial with 3 treatments:
- CLA;
- Industrial trans fatty acids (as a positive control);
- Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.
Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.
- Conditions
- Healthy
- Being tested
- Consumption of CLA enriched food
- Keywords
- CLA, Industrial trans fatty acids, Oleic acid, Controlled dietary trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of CLA enriched foodProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides
Secondary outcomes (6)
Insulin status markers : HOMA; QUICKY
Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
Fatty acid composition of cholesteryl esters and erythrocytes
proteomics
iso-prostanes
blood pressure and heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
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 HealthyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Investigators
- Ingeborg Brouwer, Dr., Principal investigator, VU University of AmsterdamMartijn Katan, Prof. Dr., Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529828
- Sponsor's protocol ID
- NL15599.081.07
- Acronym
- CLARINeT
- Status last verified
- Jan 2008
- First submitted
- 12 Sep 2007
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Smit LA, Katan MB, Wanders AJ, Basu S, Brouwer IA. A high intake of trans fatty acids has little effect on markers of inflammation and oxidative stress in humans. J Nutr. 2011 Sep;141(9):1673-8. doi: 10.3945/jn.110.134668. Epub 2011 Jul 13.
PubMed 21753062Wanders AJ, Brouwer IA, Siebelink E, Katan MB. Effect of a high intake of conjugated linoleic acid on lipoprotein levels in healthy human subjects. PLoS One. 2010 Feb 3;5(2):e9000. doi: 10.1371/journal.pone.0009000.
PubMed 20140250
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)
- ClinicalTrials.gov ID
- NCT00529828
- Acronym / sponsor ID
- CLARINeT / NL15599.081.07
- Conditions
- Healthy
- Keywords
- CLA, Industrial trans fatty acids, Oleic acid, Controlled dietary trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Sep 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.
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.
The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.
Detailed description
It will be a double-blind randomized multiple cross-over trial with 3 treatments:
- CLA;
- Industrial trans fatty acids (as a positive control);
- Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.
Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-65 years
- healthy
Key exclusion criteria (9 listed)
- serum total cholesterol >= 6,5 mmol/L
- serum triglycerides > 2,3 mmol/L
- chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- use of cholesterol lowering medication
- use of blood pressure lowering medication
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 |
|---|---|---|
| Consumption of CLA enriched food | Procedure or surgery | – |
Primary outcome
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides
6 secondary outcomes
Insulin status markers : HOMA; QUICKY
Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
Fatty acid composition of cholesteryl esters and erythrocytes
proteomics
iso-prostanes
blood pressure and heart rate
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 16 Jan 2008.
- Derived from this study: PubMed 21753062Smit LA, Katan MB, Wanders AJ, Basu S, Brouwer IA. A high intake of trans fatty acids has little effect on markers of inflammation and oxidative stress in humans. J Nutr. 2011 Sep;141(9):1673-8. doi: 10.3945/jn.110.134668. Epub 2011 Jul 13.
- Derived from this study: PubMed 20140250Wanders AJ, Brouwer IA, Siebelink E, Katan MB. Effect of a high intake of conjugated linoleic acid on lipoprotein levels in healthy human subjects. PLoS One. 2010 Feb 3;5(2):e9000. doi: 10.1371/journal.pone.0009000.
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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.
Ingeborg Brouwer, Dr. principal investigator
VU University of Amsterdam
Martijn Katan, Prof. Dr. principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of CLA enriched food in people with Healthy, run by Wageningen University at 1 site in Netherlands.
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 2 inclusion and 9 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 16 Jan 2008. 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 Netherlands. 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?
Total cholesterol. The study lists 5 primary outcomes in all. 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 NCT00529828, 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 16 Jan 2008.