HealthyNCT00449462
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function
A study testing consumption of CLA enriched food in people with Healthy, run by Wageningen University at 2 sites 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 60 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
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2007to Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-60 years
- serum total cholesterol < 8.0 mmol/L
- serum triglycerides < 3.0 mmol/L
- ALAT < 45 IU/L
- ASAT < 41 IU/L
- amylase 35-130 U/L
Show all 13Show fewer
- alkaline phosphatase 40-125 U/L
- bilirubin < 17 µmol/L
- gamma-glutamyltranspeptidase > 75 U/L (men) and < 40 U/L (women)
- lactate dehydrogenase 230-485 U/L
- creatinine clearance >= 90 mL/min
- fasting glucose levels 70-115 mg/dL
- fasting insulin levels 5-30 mU/L
Who cannot join
- use of cholesterol lowering medication
- high alcohol intake
- BMI > 30
- chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VU University Amsterdam, Institute for Health Sciences
Amsterdam
Wageningen University, Division of Human Nutrition
Wageningen
About this study
Official title: The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-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 CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.
Read the detailed description
Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.
- Conditions
- Healthy
- Being tested
- consumption of CLA enriched food
- Keywords
- CLA, liver, kidney
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.
ALAT
ASAT
amylase
bilirubin
alkaline phosphatase
gamma-glutamyltranspeptidase
lactate dehydrogenase
creatinine clearance
Secondary outcomes (5)
total cholesterol
HDL cholesterol
LDL cholesterol
triglycerides
fatty acids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Study completionJun 2007
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Investigators
- Ingeborg A Brouwer, PhD, Principal investigator, VU University of AmsterdamMartijn B Katan, Professor, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449462
- Sponsor's protocol ID
- NL15420.081.06
- Status last verified
- Mar 2007
- First submitted
- 19 Mar 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wanders AJ, Leder L, Banga JD, Katan MB, Brouwer IA. A high intake of conjugated linoleic acid does not affect liver and kidney function tests in healthy human subjects. Food Chem Toxicol. 2010 Feb;48(2):587-90. doi: 10.1016/j.fct.2009.11.036. Epub 2009 Nov 22.
PubMed 19932729
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)
- ClinicalTrials.gov ID
- NCT00449462
- Acronym / sponsor ID
- NL15420.081.06
- Conditions
- Healthy
- Keywords
- CLA, liver, kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- Mar 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Mar 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 CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.
Detailed description
Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- age 18-60 years
- serum total cholesterol < 8.0 mmol/L
- serum triglycerides < 3.0 mmol/L
- ALAT < 45 IU/L
- ASAT < 41 IU/L
Key exclusion criteria (5 listed)
- use of cholesterol lowering medication
- high alcohol intake
- BMI > 30
- chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- pregnancy
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
ALAT
ASAT
amylase
bilirubin
alkaline phosphatase
gamma-glutamyltranspeptidase
lactate dehydrogenase
creatinine clearance
5 secondary outcomes
total cholesterol
HDL cholesterol
LDL cholesterol
triglycerides
fatty acids
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 6 Jul 2007.
- Derived from this study: PubMed 19932729Wanders AJ, Leder L, Banga JD, Katan MB, Brouwer IA. A high intake of conjugated linoleic acid does not affect liver and kidney function tests in healthy human subjects. Food Chem Toxicol. 2010 Feb;48(2):587-90. doi: 10.1016/j.fct.2009.11.036. Epub 2009 Nov 22.
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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 A Brouwer, PhD principal investigator
VU University of Amsterdam
Martijn B Katan, Professor principal investigator
VU University of Amsterdam
2 sites 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 2 sites 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 13 inclusion and 5 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 6 Jul 2007. 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 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?
ALAT. The study lists 8 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 NCT00449462, 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 6 Jul 2007.