Conjugated Linoleic Acid in Obese Women (CLA)
Primary Purpose
Lipid Metabolism Disorders, Obesity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CLA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Metabolism Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Had frequency to training sessions below 85% of the total sessions
Sites / Locations
- Universidade Estadual de Londrina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aerobic exercise associated with CLA
Aerobic exercise
Arm Description
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%).
Placebo group received 4 g/day of olive oil.
Outcomes
Primary Outcome Measures
Body fat
Dual-energy X-ray absorptiometry
Secondary Outcome Measures
Total cholesterol
Blood analysis
Triglycerides
Blood analysis
High-density lipoprotein
Blood analysis
Low-density lipoprotein
Estimated by Friedewald formula
Trunk fat
Dual-energy X-ray absorptiometry
Arm fat
Dual-energy X-ray absorptiometry
Leg fat
Dual-energy X-ray absorptiometry
Full Information
NCT ID
NCT02529046
First Posted
August 4, 2015
Last Updated
August 18, 2015
Sponsor
Universidade Estadual de Londrina
1. Study Identification
Unique Protocol Identification Number
NCT02529046
Brief Title
Conjugated Linoleic Acid in Obese Women
Acronym
CLA
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise associated with CLA
Arm Type
Active Comparator
Arm Description
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%).
Arm Title
Aerobic exercise
Arm Type
Placebo Comparator
Arm Description
Placebo group received 4 g/day of olive oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
CLA
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Placebo group received 4 g/day of olive oil. Aerobic exercise
Primary Outcome Measure Information:
Title
Body fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Blood analysis
Time Frame
8 weeks
Title
Triglycerides
Description
Blood analysis
Time Frame
8 weeks
Title
High-density lipoprotein
Description
Blood analysis
Time Frame
8 weeks
Title
Low-density lipoprotein
Description
Estimated by Friedewald formula
Time Frame
8 weeks
Title
Trunk fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Title
Arm fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Title
Leg fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Body mass
Description
Urano, model PS 180
Time Frame
8 weeks
Title
Maximum oxygen uptake
Description
incremental treadmill test
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Had frequency to training sessions below 85% of the total sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edilson Cyrino, PhD
Organizational Affiliation
Universidade Estadual de Londrina
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Estadual de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86.057-970
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18500970
Citation
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.
Results Reference
result
PubMed Identifier
25475010
Citation
Alkerwi 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 Reference
result
PubMed Identifier
16556311
Citation
Banu 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 Reference
result
PubMed Identifier
16650752
Citation
Bhattacharya 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 Reference
result
PubMed Identifier
11110851
Citation
Blankson 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 Reference
result
PubMed Identifier
23271912
Citation
Carvalho 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 Reference
result
PubMed Identifier
17119522
Citation
Colakoglu 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 Reference
result
PubMed Identifier
10655980
Citation
de 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 Reference
result
PubMed Identifier
17313269
Citation
Di 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 Reference
result
PubMed Identifier
17531459
Citation
Diaz 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 Reference
result
PubMed Identifier
22452730
Citation
Dilzer 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 Reference
result
PubMed Identifier
24600599
Citation
Eftekhari 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.
Results Reference
result
PubMed Identifier
4337382
Citation
Friedewald 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.
Results Reference
result
PubMed Identifier
21694556
Citation
Garber 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.
Results Reference
result
PubMed Identifier
17313718
Citation
Gaullier 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.
Results Reference
result
PubMed Identifier
17299124
Citation
Hill AM, LaForgia J, Coates AM, Buckley JD, Howe PR. Estimating abdominal adipose tissue with DXA and anthropometry. Obesity (Silver Spring). 2007 Feb;15(2):504-10. doi: 10.1038/oby.2007.629.
Results Reference
result
PubMed Identifier
25034667
Citation
Jenkins ND, Buckner SL, Cochrane KC, Bergstrom HC, Goldsmith JA, Weir JP, Housh TJ, Cramer JT. CLA supplementation and aerobic exercise lower blood triacylglycerol, but have no effect on peak oxygen uptake or cardiorespiratory fatigue thresholds. Lipids. 2014 Sep;49(9):871-80. doi: 10.1007/s11745-014-3929-0. Epub 2014 Jul 18.
Results Reference
result
PubMed Identifier
19954947
Citation
Kennedy A, Martinez K, Schmidt S, Mandrup S, LaPoint K, McIntosh M. Antiobesity mechanisms of action of conjugated linoleic acid. J Nutr Biochem. 2010 Mar;21(3):171-9. doi: 10.1016/j.jnutbio.2009.08.003. Epub 2009 Dec 1.
Results Reference
result
PubMed Identifier
17381964
Citation
Lambert EV, Goedecke JH, Bluett K, Heggie K, Claassen A, Rae DE, West S, Dugas J, Dugas L, Meltzeri S, Charlton K, Mohede I. Conjugated linoleic acid versus high-oleic acid sunflower oil: effects on energy metabolism, glucose tolerance, blood lipids, appetite and body composition in regularly exercising individuals. Br J Nutr. 2007 May;97(5):1001-11. doi: 10.1017/S0007114507172822.
Results Reference
result
PubMed Identifier
12923219
Citation
Larsen TM, Toubro S, Astrup A. Efficacy and safety of dietary supplements containing CLA for the treatment of obesity: evidence from animal and human studies. J Lipid Res. 2003 Dec;44(12):2234-41. doi: 10.1194/jlr.R300011-JLR200. Epub 2003 Aug 16.
Results Reference
result
PubMed Identifier
1858692
Citation
Mertz W, Tsui JC, Judd JT, Reiser S, Hallfrisch J, Morris ER, Steele PD, Lashley E. What are people really eating? The relation between energy intake derived from estimated diet records and intake determined to maintain body weight. Am J Clin Nutr. 1991 Aug;54(2):291-5. doi: 10.1093/ajcn/54.2.291.
Results Reference
result
PubMed Identifier
23285120
Citation
Mitchell PL, Karakach TK, Currie DL, McLeod RS. t-10, c-12 CLA dietary supplementation inhibits atherosclerotic lesion development despite adverse cardiovascular and hepatic metabolic marker profiles. PLoS One. 2012;7(12):e52634. doi: 10.1371/journal.pone.0052634. Epub 2012 Dec 20.
Results Reference
result
PubMed Identifier
25446861
Citation
Moon HS. Biological effects of conjugated linoleic acid on obesity-related cancers. Chem Biol Interact. 2014 Dec 5;224:189-95. doi: 10.1016/j.cbi.2014.11.006. Epub 2014 Nov 18.
Results Reference
result
PubMed Identifier
12031264
Citation
Mougios V, Matsakas A, Petridou A, Ring S, Sagredos A, Melissopoulou A, Tsigilis N, Nikolaidis M. Effect of supplementation with conjugated linoleic acid on human serum lipids and body fat. J Nutr Biochem. 2001 Oct;12(10):585-594. doi: 10.1016/s0955-2863(01)00177-2.
Results Reference
result
PubMed Identifier
21990002
Citation
Onakpoya IJ, Posadzki PP, Watson LK, Davies LA, Ernst E. The efficacy of long-term conjugated linoleic acid (CLA) supplementation on body composition in overweight and obese individuals: a systematic review and meta-analysis of randomized clinical trials. Eur J Nutr. 2012 Mar;51(2):127-34. doi: 10.1007/s00394-011-0253-9. Epub 2011 Oct 12.
Results Reference
result
PubMed Identifier
10632956
Citation
Pariza MW, Park Y, Cook ME. Mechanisms of action of conjugated linoleic acid: evidence and speculation. Proc Soc Exp Biol Med. 2000 Jan;223(1):8-13. doi: 10.1046/j.1525-1373.2000.22302.x.
Results Reference
result
PubMed Identifier
11412893
Citation
Pariza MW, Park Y, Cook ME. The biologically active isomers of conjugated linoleic acid. Prog Lipid Res. 2001 Jul;40(4):283-98. doi: 10.1016/s0163-7827(01)00008-x.
Results Reference
result
PubMed Identifier
16531905
Citation
Pinkoski C, Chilibeck PD, Candow DG, Esliger D, Ewaschuk JB, Facci M, Farthing JP, Zello GA. The effects of conjugated linoleic acid supplementation during resistance training. Med Sci Sports Exerc. 2006 Feb;38(2):339-48. doi: 10.1249/01.mss.0000183860.42853.15.
Results Reference
result
PubMed Identifier
11570117
Citation
Poirier P, Despres JP. Exercise in weight management of obesity. Cardiol Clin. 2001 Aug;19(3):459-70. doi: 10.1016/s0733-8651(05)70229-0.
Results Reference
result
PubMed Identifier
24969229
Citation
Qi R, Yang F, Huang J, Peng H, Liu Y, Liu Z. Supplementation with conjugated linoeic acid decreases pig back fat deposition by inducing adipocyte apoptosis. BMC Vet Res. 2014 Jun 26;10:141. doi: 10.1186/1746-6148-10-141.
Results Reference
result
PubMed Identifier
12196420
Citation
Riserus U, Arner P, Brismar K, Vessby B. Treatment with dietary trans10cis12 conjugated linoleic acid causes isomer-specific insulin resistance in obese men with the metabolic syndrome. Diabetes Care. 2002 Sep;25(9):1516-21. doi: 10.2337/diacare.25.9.1516.
Results Reference
result
PubMed Identifier
11477497
Citation
Riserus U, Berglund L, Vessby B. Conjugated linoleic acid (CLA) reduced abdominal adipose tissue in obese middle-aged men with signs of the metabolic syndrome: a randomised controlled trial. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1129-35. doi: 10.1038/sj.ijo.0801659.
Results Reference
result
PubMed Identifier
22833652
Citation
Ritzenthaler KL, Shahin AM, Shultz TD, Dasgupta N, McGuire MA, McGuire MK. Dietary intake of c9,t11-conjugated linoleic acid correlates with its concentration in plasma lipid fractions of men but not women. J Nutr. 2012 Sep;142(9):1645-51. doi: 10.3945/jn.111.156794. Epub 2012 Jul 25.
Results Reference
result
PubMed Identifier
16864141
Citation
Salas-Salvado J, Marquez-Sandoval F, Bullo M. Conjugated linoleic acid intake in humans: a systematic review focusing on its effect on body composition, glucose, and lipid metabolism. Crit Rev Food Sci Nutr. 2006;46(6):479-88. doi: 10.1080/10408390600723953.
Results Reference
result
PubMed Identifier
19923377
Citation
Sluijs I, Plantinga Y, de Roos B, Mennen LI, Bots ML. Dietary supplementation with cis-9,trans-11 conjugated linoleic acid and aortic stiffness in overweight and obese adults. Am J Clin Nutr. 2010 Jan;91(1):175-83. doi: 10.3945/ajcn.2009.28192. Epub 2009 Nov 18.
Results Reference
result
PubMed Identifier
17449580
Citation
Steck SE, Chalecki AM, Miller P, Conway J, Austin GL, Hardin JW, Albright CD, Thuillier P. Conjugated linoleic acid supplementation for twelve weeks increases lean body mass in obese humans. J Nutr. 2007 May;137(5):1188-93. doi: 10.1093/jn/137.5.1188.
Results Reference
result
PubMed Identifier
17912368
Citation
Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.
Results Reference
result
PubMed Identifier
11725826
Citation
Thom E, Wadstein J, Gudmundsen O. Conjugated linoleic acid reduces body fat in healthy exercising humans. J Int Med Res. 2001 Sep-Oct;29(5):392-6. doi: 10.1177/147323000102900503. Erratum In: J Int Med Res 2002 Mar-Apr;30(2):210. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.
Results Reference
result
PubMed Identifier
10969838
Citation
Tsuboyama-Kasaoka N, Takahashi M, Tanemura K, Kim HJ, Tange T, Okuyama H, Kasai M, Ikemoto S, Ezaki O. Conjugated linoleic acid supplementation reduces adipose tissue by apoptosis and develops lipodystrophy in mice. Diabetes. 2000 Sep;49(9):1534-42. doi: 10.2337/diabetes.49.9.1534.
Results Reference
result
PubMed Identifier
20140250
Citation
Wanders 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.
Results Reference
result
PubMed Identifier
11592726
Citation
Zambell KL, Horn WF, Keim NL. Conjugated linoleic acid supplementation in humans: effects on fatty acid and glycerol kinetics. Lipids. 2001 Aug;36(8):767-72. doi: 10.1007/s11745-001-0783-8.
Results Reference
result
Learn more about this trial
Conjugated Linoleic Acid in Obese Women
We'll reach out to this number within 24 hrs