Lipid Metabolism DisordersCLANCT02529046
Conjugated Linoleic Acid in Obese Women
A study testing CLA in people with Lipid Metabolism Disorders and Obesity, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders, Obesity
- What is being tested?
- CLA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2007to Jul 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Had no signs or symptoms of disease
- No orthopedic injuries
- Must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week)
- Must be non-smokers
- Must be free from the use of ergogenic aids
- Had no metabolic disorders or chronic degenerative diseases
- Not use drug therapy for body mass loss.
Who cannot join
- Had frequency to training sessions below 85% of the total sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Conjugated Linoleic Acid Associated With Aerobic Exercise on Body Fat and Lipid Profile in Obese Women: A Randomized, Double-blinded and Placebo-controlled Trial
In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women.
Read the detailed description
The aim of this investigation was to analyze the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women. The investigators performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/d of CLA or 4 g/d of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat (DXA) and biochemical analysis (blood sample) were assessed before and after the intervention period.
- Conditions
- Lipid Metabolism Disorders, Obesity
- Being tested
- CLA, Placebo
- Medical subject headings
- Lipid Metabolism Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLADietary supplement
CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Aerobic exercise associated with CLA
PlaceboBehavioural
Placebo group received 4 g/day of olive oil. Aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise associated with CLA | Active comparator | CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Receives: Dietary Supplement: CLA |
| Aerobic exercise | Placebo comparator | Placebo group received 4 g/day of olive oil. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Dual-energy X-ray absorptiometry
Measured: 8 weeks
Secondary outcomes (7)
Total cholesterol
Blood analysis
Measured: 8 weeks
Triglycerides
Blood analysis
Measured: 8 weeks
High-density lipoprotein
Blood analysis
Measured: 8 weeks
Low-density lipoprotein
Estimated by Friedewald formula
Measured: 8 weeks
Trunk fat
Dual-energy X-ray absorptiometry
Measured: 8 weeks
Arm fat
Dual-energy X-ray absorptiometry
Measured: 8 weeks
Leg fat
Dual-energy X-ray absorptiometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMar 2007
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edilson Serpeloni Cyrino, Universidade Estadual de Londrina
- Investigators
- Edilson Cyrino, PhD, Study chair, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529046
- Sponsor's protocol ID
- ESCyrino
- Acronym
- CLA
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams RE, Hsueh A, Alford B, King C, Mo H, Wildman R. Conjugated linoleic Acid supplementation does not reduce visceral adipose tissue in middle-aged men engaged in a resistance-training program. J Int Soc Sports Nutr. 2006 Dec 13;3(2):28-36. doi: 10.1186/1550-2783-3-2-28.
PubMed 18500970Alkerwi A, Vernier C, Crichton GE, Sauvageot N, Shivappa N, Hebert JR. Cross-comparison of diet quality indices for predicting chronic disease risk: findings from the Observation of Cardiovascular Risk Factors in Luxembourg (ORISCAV-LUX) study. Br J Nutr. 2015 Jan 28;113(2):259-69. doi: 10.1017/S0007114514003456. Epub 2014 Dec 5.
PubMed 25475010Banu J, Bhattacharya A, Rahman M, O'Shea M, Fernandes G. Effects of conjugated linoleic acid and exercise on bone mass in young male Balb/C mice. Lipids Health Dis. 2006 Mar 23;5:7. doi: 10.1186/1476-511X-5-7.
PubMed 16556311Bhattacharya A, Banu J, Rahman M, Causey J, Fernandes G. Biological effects of conjugated linoleic acids in health and disease. J Nutr Biochem. 2006 Dec;17(12):789-810. doi: 10.1016/j.jnutbio.2006.02.009. Epub 2006 May 2.
PubMed 16650752Blankson H, Stakkestad JA, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Conjugated linoleic acid reduces body fat mass in overweight and obese humans. J Nutr. 2000 Dec;130(12):2943-8. doi: 10.1093/jn/130.12.2943.
PubMed 11110851Carvalho RF, Uehara SK, Rosa G. Microencapsulated conjugated linoleic acid associated with hypocaloric diet reduces body fat in sedentary women with metabolic syndrome. Vasc Health Risk Manag. 2012;8:661-7. doi: 10.2147/VHRM.S37385. Epub 2012 Dec 13.
PubMed 23271912Colakoglu S, Colakoglu M, Taneli F, Cetinoz F, Turkmen M. Cumulative effects of conjugated linoleic acid and exercise on endurance development, body composition, serum leptin and insulin levels. J Sports Med Phys Fitness. 2006 Dec;46(4):570-7.
PubMed 17119522de Deckere EA, van Amelsvoort JM, McNeill GP, Jones P. Effects of conjugated linoleic acid (CLA) isomers on lipid levels and peroxisome proliferation in the hamster. Br J Nutr. 1999 Oct;82(4):309-17.
PubMed 10655980Di Felice V, Macaluso F, Montalbano A, Gammazza AM, Palumbo D, Angelone T, Bellafiore M, Farina F. Effects of conjugated linoleic acid and endurance training on peripheral blood and bone marrow of trained mice. J Strength Cond Res. 2007 Feb;21(1):193-8. doi: 10.1519/00124278-200702000-00035.
PubMed 17313269Diaz ML, Watkins BA, Li Y, Anderson RA, Campbell WW. Chromium picolinate and conjugated linoleic acid do not synergistically influence diet- and exercise-induced changes in body composition and health indexes in overweight women. J Nutr Biochem. 2008 Jan;19(1):61-8. doi: 10.1016/j.jnutbio.2007.01.006. Epub 2007 May 24.
PubMed 17531459Dilzer A, Park Y. Implication of conjugated linoleic acid (CLA) in human health. Crit Rev Food Sci Nutr. 2012;52(6):488-513. doi: 10.1080/10408398.2010.501409.
PubMed 22452730Eftekhari MH, Aliasghari F, Beigi MA, Hasanzadeh J. The effect of conjugated linoleic acids and omega-3 fatty acids supplementation on lipid profile in atherosclerosis. Adv Biomed Res. 2014 Jan 9;3:15. doi: 10.4103/2277-9175.124644. eCollection 2014.
PubMed 24600599Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
PubMed 4337382Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Gaullier JM, Halse J, Hoivik HO, Hoye K, Syvertsen C, Nurminiemi M, Hassfeld C, Einerhand A, O'Shea M, Gudmundsen O. Six months supplementation with conjugated linoleic acid induces regional-specific fat mass decreases in overweight and obese. Br J Nutr. 2007 Mar;97(3):550-60. doi: 10.1017/S0007114507381324.
PubMed 17313718
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conjugated Linoleic Acid Associated With Aerobic Exercise on Body Fat and Lipid Profile in Obese Women: A Randomized, Double-blinded and Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02529046
- Acronym / sponsor ID
- CLA / ESCyrino
- Conditions
- Lipid Metabolism Disorders, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Aug 2015 (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.
In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women.
Detailed description
The aim of this investigation was to analyze the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women. The investigators performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/d of CLA or 4 g/d of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat (DXA) and biochemical analysis (blood sample) were assessed before and after the intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise associated with CLA | Active comparator | Dietary Supplement: CLACLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). |
| Aerobic exercise | Placebo comparator | Behavioral: PlaceboPlacebo group received 4 g/day of olive oil. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Had no signs or symptoms of disease
- No orthopedic injuries
- Must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week)
- Must be non-smokers
- Must be free from the use of ergogenic aids
Key exclusion criteria (1 listed)
- Had frequency to training sessions below 85% of the total sessions
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 |
|---|---|---|
| CLACLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Aerobic exercise associated with CLA | Dietary supplement | Aerobic exercise associated with CLA |
| PlaceboPlacebo group received 4 g/day of olive oil. Aerobic exercise | Behavioural | Aerobic exercise |
Primary outcome
Body fat
Time frame: 8 weeks
Dual-energy X-ray absorptiometry
7 secondary outcomes
Total cholesterol
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
High-density lipoprotein
Time frame: 8 weeks
Low-density lipoprotein
Time frame: 8 weeks
Trunk fat
Time frame: 8 weeks
Arm fat
Time frame: 8 weeks
Leg fat
Time frame: 8 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 19 Aug 2015.
- Results publication: PubMed 18500970Adams RE, Hsueh A, Alford B, King C, Mo H, Wildman R. Conjugated linoleic Acid supplementation does not reduce visceral adipose tissue in middle-aged men engaged in a resistance-training program. J Int Soc Sports Nutr. 2006 Dec 13;3(2):28-36. doi: 10.1186/1550-2783-3-2-28.
- Results publication: PubMed 25475010Alkerwi A, Vernier C, Crichton GE, Sauvageot N, Shivappa N, Hebert JR. Cross-comparison of diet quality indices for predicting chronic disease risk: findings from the Observation of Cardiovascular Risk Factors in Luxembourg (ORISCAV-LUX) study. Br J Nutr. 2015 Jan 28;113(2):259-69. doi: 10.1017/S0007114514003456. Epub 2014 Dec 5.
- Results publication: PubMed 16556311Banu J, Bhattacharya A, Rahman M, O'Shea M, Fernandes G. Effects of conjugated linoleic acid and exercise on bone mass in young male Balb/C mice. Lipids Health Dis. 2006 Mar 23;5:7. doi: 10.1186/1476-511X-5-7.
- Results publication: PubMed 16650752Bhattacharya A, Banu J, Rahman M, Causey J, Fernandes G. Biological effects of conjugated linoleic acids in health and disease. J Nutr Biochem. 2006 Dec;17(12):789-810. doi: 10.1016/j.jnutbio.2006.02.009. Epub 2006 May 2.
- Results publication: PubMed 11110851Blankson H, Stakkestad JA, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Conjugated linoleic acid reduces body fat mass in overweight and obese humans. J Nutr. 2000 Dec;130(12):2943-8. doi: 10.1093/jn/130.12.2943.
- Results publication: PubMed 23271912Carvalho RF, Uehara SK, Rosa G. Microencapsulated conjugated linoleic acid associated with hypocaloric diet reduces body fat in sedentary women with metabolic syndrome. Vasc Health Risk Manag. 2012;8:661-7. doi: 10.2147/VHRM.S37385. Epub 2012 Dec 13.
- Results publication: PubMed 17119522Colakoglu S, Colakoglu M, Taneli F, Cetinoz F, Turkmen M. Cumulative effects of conjugated linoleic acid and exercise on endurance development, body composition, serum leptin and insulin levels. J Sports Med Phys Fitness. 2006 Dec;46(4):570-7.
- Results publication: PubMed 10655980de Deckere EA, van Amelsvoort JM, McNeill GP, Jones P. Effects of conjugated linoleic acid (CLA) isomers on lipid levels and peroxisome proliferation in the hamster. Br J Nutr. 1999 Oct;82(4):309-17.
- Results publication: PubMed 17313269Di Felice V, Macaluso F, Montalbano A, Gammazza AM, Palumbo D, Angelone T, Bellafiore M, Farina F. Effects of conjugated linoleic acid and endurance training on peripheral blood and bone marrow of trained mice. J Strength Cond Res. 2007 Feb;21(1):193-8. doi: 10.1519/00124278-200702000-00035.
- Results publication: PubMed 17531459Diaz ML, Watkins BA, Li Y, Anderson RA, Campbell WW. Chromium picolinate and conjugated linoleic acid do not synergistically influence diet- and exercise-induced changes in body composition and health indexes in overweight women. J Nutr Biochem. 2008 Jan;19(1):61-8. doi: 10.1016/j.jnutbio.2007.01.006. Epub 2007 May 24.
- Results publication: PubMed 22452730Dilzer A, Park Y. Implication of conjugated linoleic acid (CLA) in human health. Crit Rev Food Sci Nutr. 2012;52(6):488-513. doi: 10.1080/10408398.2010.501409.
- Results publication: PubMed 24600599Eftekhari MH, Aliasghari F, Beigi MA, Hasanzadeh J. The effect of conjugated linoleic acids and omega-3 fatty acids supplementation on lipid profile in atherosclerosis. Adv Biomed Res. 2014 Jan 9;3:15. doi: 10.4103/2277-9175.124644. eCollection 2014.
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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.
Edilson Cyrino, PhD study chair
Universidade Estadual de Londrina
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 in people with Lipid Metabolism Disorders and Obesity, run by Universidade Estadual de Londrina 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 7 inclusion and 1 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 19 Aug 2015. 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. 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.
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?
Body fat (time frame: 8 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 NCT02529046, which also lists 41 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 19 Aug 2015.