Dietary ModificationNCT01841645
CLA Metabolism and Effects on Human Health
A study testing CLA depletion-repletion in people with Dietary Modification and Inflammation, run by Alexandre Guedes Torres at 1 site in Brazil.
Trial summary
The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Inflammation, Body Composition, Beneficial
- What is being tested?
- CLA depletion-repletion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Oct 2010
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers;
- 20 to 40 years;
- BMI between 18.0 and 29.9 kg/m2.
Who cannot join
- Use of dietary supplements;
- Smoker;
- Alcoholic;
- Under medication;
- History of chronic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-909
About this study
Official title: Conjugated Linoleic Acid (CLA) Depletion-repletion: Metabolism and Bioactivity in Humans
The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.
Read the detailed description
After collecting baseline blood samples, CLA-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a CLA-enriched butter for another 8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of CLA on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.
- Being tested
- CLA depletion-repletion
- Keywords
- CLA-enriched butter, CLA metabolism, inflammation
- Medical subject headings
- Inflammation, Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLA depletion-repletionDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| CLA depletion-repletion | Other | Not described Receives: Dietary Supplement: CLA depletion-repletion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention
Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membrane stability, plasma lipid levels and fatty acid composition of lipid classes were evaluated before and after depletion and repletion phases.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandre Guedes Torres
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Sponsor-investigator, Alexandre Guedes Torres, Universidade Federal do Rio de Janeiro
- Investigators
- Alexandre G Torres, DSc, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841645
- Sponsor's protocol ID
- AGT2013
- Status last verified
- May 2013
- First submitted
- 17 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjugated Linoleic Acid (CLA) Depletion-repletion: Metabolism and Bioactivity in Humans
- ClinicalTrials.gov ID
- NCT01841645
- Acronym / sponsor ID
- AGT2013
- Keywords
- CLA-enriched butter, CLA metabolism, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Alexandre Guedes TorresUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Apr 2013 (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 purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.
Detailed description
After collecting baseline blood samples, CLA-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a CLA-enriched butter for another 8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of CLA on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLA depletion-repletion | Other | Dietary Supplement: CLA depletion-repletion |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers;
- 20 to 40 years;
- BMI between 18.0 and 29.9 kg/m2.
Key exclusion criteria (5 listed)
- Use of dietary supplements;
- Smoker;
- Alcoholic;
- Under medication;
- History of chronic disease
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 |
|---|---|---|
| CLA depletion-repletion | Dietary supplement | CLA depletion-repletion |
Primary outcome
Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention
Time frame: 16 weeks
Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membrane stability, plasma lipid levels and fatty acid composition of lipid classes were evaluated before and after depletion and repletion phases.
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 3 May 2013.
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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.
Alexandre G Torres, DSc principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLA depletion-repletion in people with Dietary Modification and Inflammation, run by Alexandre Guedes Torres at 1 site in Brazil.
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 3 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 3 May 2013. 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 Brazil. 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?
Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention (time frame: 16 weeks). 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 3 May 2013.