Body WeightPhase 1CLANCT01047280
Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans
A Phase 1 study testing Clarinol G-80 ® treatment, Safflower oil and G-c9, t11 in people with Body Weight and Body Composition, run by University of Manitoba.
Trial summary
The purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Body Composition, Hyperlipidemia
- What is being tested?
- Clarinol G-80 ® treatment, Safflower oil and G-c9, t11
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to May 2009
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study.
Who cannot join
- subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study;
- subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;
- subjects who currently have diabetes, kidney, heart or liver disease or have had any of these diseases at any time during the past 3 months. In addition any development of diabetes mellitus, kidney, heart or liver disease during the trial will lead to exclusion from the trial;
- subjects who smoke or consume large amounts of alcohol (> 2 drinks/day);
- subjects who have any major food allergies or are vegetarian;
- subjects that use natural or pharmaceutical weight loss supplements or products known to affect lipid metabolism at the beginning and end of each treatment period as well as the washout periods;
- subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed, marigolds, daisies).
About this study
The purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. The CLA will be supplemented in an oil form and will be added to solid foods as provided by the metabolic kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).
Read the detailed description
In order to investigate the effectiveness of CLA on body weight and composition, as well as blood lipids, a double-blinded, 3-phase crossover trial will be conducted in moderately overweight (BMI=25-40 kg/m2), borderline hypercholesterolemic (LDL-C ≥ 2.5 mmol/L) men between the ages of 18-60 years. During three 8-week phases separated by 4-week washout periods, and under supervision to ensure compliance, 28 subjects will consume in random order (i) Control: 3.5 g/d of safflower oil, (ii) Clarinol G-80®: 3.5 g/d of 50:50 mixture of t10, c12 and c9, t11 CLA and (iii) c9, t11: 3.5 g/day of c9, t11 CLA. Body weight, fat mass and lean body mass will be measured at beginning and end of each phase by dual energy X-ray absorptiometry (DEXA). Baseline and endpoint blood samples will collected to determine blood lipid profile, and different safety parameters, including insulin sensitivity (HOMA-IR index), and concentrations of inflammatory (hs-CRP, TNF-α, IL-6) and oxidative (Oxidized-LDL) biomarkers. Effect of CLA consumption on fatty acid oxidation will also be measured.
- Conditions
- Body Weight, Body Composition, Hyperlipidemia, Inflammation, Oxidative Stress
- Being tested
- Clarinol G-80 ® treatment, Safflower oil, G-c9, t11
- Keywords
- Conjugated linoleic acid, Body weight, Body composition, Blood lipid profile, Body inflammatory and oxidative status
- Medical subject headings
- Body Weight, Hyperlipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarinol G-80 ® treatmentDietary supplement
dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).
Safflower oilDietary supplement
3.5 g/d of safflower oil
G-c9, t11Dietary supplement
3.5 g/day of c9, t11 CLA
| Study group | Role | What they receive |
|---|---|---|
| Safflower oil | Placebo comparator | This arm of the study constitutes the control phase Receives: Dietary Supplement: Safflower oil |
| Clarinol G-80® | Experimental | Not described Receives: Dietary Supplement: Clarinol G-80 ® treatment |
| G-c9, t11 | Experimental | Not described Receives: Dietary Supplement: G-c9, t11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight, body fat mass, and lean body mass
Measured: At baseline and endpoint of each phase
Secondary outcomes (1)
Changes in inflammation and oxidation markers
Measured: At baseline and endpoint of each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMay 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 Body WeightStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Peter JH Jones, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047280
- Sponsor's protocol ID
- B2005:183
- Acronym
- CLA
- Status last verified
- Dec 2009
- First submitted
- 8 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joseph SV, Jacques H, Plourde M, Mitchell PL, McLeod RS, Jones PJ. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men. J Nutr. 2011 Jul;141(7):1286-91. doi: 10.3945/jn.110.135087. Epub 2011 May 18.
PubMed 21593349
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans
- ClinicalTrials.gov ID
- NCT01047280
- Acronym / sponsor ID
- CLA / B2005:183
- Conditions
- Body Weight, Body Composition, Hyperlipidemia, Inflammation, Oxidative Stress
- Keywords
- Conjugated linoleic acid, Body weight, Body composition, Blood lipid profile, Body inflammatory and oxidative status
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Jan 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 purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. The CLA will be supplemented in an oil form and will be added to solid foods as provided by the metabolic kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).
Detailed description
In order to investigate the effectiveness of CLA on body weight and composition, as well as blood lipids, a double-blinded, 3-phase crossover trial will be conducted in moderately overweight (BMI=25-40 kg/m2), borderline hypercholesterolemic (LDL-C ≥ 2.5 mmol/L) men between the ages of 18-60 years. During three 8-week phases separated by 4-week washout periods, and under supervision to ensure compliance, 28 subjects will consume in random order (i) Control: 3.5 g/d of safflower oil, (ii) Clarinol G-80®: 3.5 g/d of 50:50 mixture of t10, c12 and c9, t11 CLA and (iii) c9, t11: 3.5 g/day of c9, t11 CLA. Body weight, fat mass and lean body mass will be measured at beginning and end of each phase by dual energy X-ray absorptiometry (DEXA). Baseline and endpoint blood samples will collected to determine blood lipid profile, and different safety parameters, including insulin sensitivity (HOMA-IR index), and concentrations of inflammatory (hs-CRP, TNF-α, IL-6) and oxidative (Oxidized-LDL) biomarkers. Effect of CLA consumption on fatty acid oxidation will also be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safflower oil | Placebo comparator | Dietary Supplement: Safflower oilThis arm of the study constitutes the control phase |
| Clarinol G-80® | Experimental | Dietary Supplement: Clarinol G-80 ® treatment |
| G-c9, t11 | Experimental | Dietary Supplement: G-c9, t11 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study.
Key exclusion criteria (7 listed)
- subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study;
- subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;
- subjects who currently have diabetes, kidney, heart or liver disease or have had any of these diseases at any time during the past 3 months. In addition any development of diabetes mellitus, kidney, heart or liver disease during the trial will lead to exclusion from the trial;
- subjects who smoke or consume large amounts of alcohol (> 2 drinks/day);
- subjects who have any major food allergies or are vegetarian;
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 |
|---|---|---|
| Clarinol G-80 ® treatmentdietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%). | Dietary supplement | Clarinol G-80® |
| Safflower oil3.5 g/d of safflower oil | Dietary supplement | Safflower oil |
| G-c9, t113.5 g/day of c9, t11 CLA | Dietary supplement | G-c9, t11 |
Primary outcome
Changes in body weight, body fat mass, and lean body mass
Time frame: At baseline and endpoint of each phase
1 secondary outcome
Changes in inflammation and oxidation markers
Time frame: At baseline and endpoint of each phase
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 12 Jan 2010.
- Derived from this study: PubMed 21593349Joseph SV, Jacques H, Plourde M, Mitchell PL, McLeod RS, Jones PJ. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men. J Nutr. 2011 Jul;141(7):1286-91. doi: 10.3945/jn.110.135087. Epub 2011 May 18.
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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.
Peter JH Jones, Ph.D. principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clarinol G-80 ® treatment, Safflower oil and G-c9, t11 in people with Body Weight and Body Composition, run by University of Manitoba.
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 1 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in body weight, body fat mass, and lean body mass (time frame: At baseline and endpoint of each phase). 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 NCT01047280, 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 12 Jan 2010; AzTrials last refreshed its copy on 7 Nov 2026.