ObesityNCT02656940
Dietary Lipids, Energy Expenditure and Obesity Biomarkers
A study testing Group 1 - diet rich in n-3 and n-6 PUFA and Group 2 - diet rich in MUFA in people with Obesity, run by Universidade Federal do Rio de Janeiro.
Trial summary
The purpose of this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Group 1 - diet rich in n-3 and n-6 PUFA and Group 2 - diet rich in MUFA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jul 2014
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
- completion of basic education (former 4th primary series).
Who cannot join
- menopausal;
- weight loss more than three kilograms (3 kg) in the last three months;
- diagnosis of diabetes mellitus, heart disease, hypertension, nephropathy, liver diseases , thyroid dysfunction; gastrointestinal disorders , acquired immunodeficiency syndrome or cancer;
- cholecystectomy in the past 12 months and other recent surgeries;
- pregnancy or lactation;
- smokers;
- drugs to lipid-lowering, diabetes, hypertension, depression, or obesity;
- food history of allergy or intolerance to vegetable oils (olive oil, soy or canola), fish oil, fish and / or seafood.
About this study
Official title: Effects of Dietary Lipid Modulation in Energy Expenditure, Body Composition, Obesity-related Biomarkers and Gene Expression of Peroxisome Proliferator-Activated Receptors Alpha and Gamma 2 in Adipose Tissue of Obese Women
The purpose of this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities.
Read the detailed description
Obesity is a complex disease of multifactorial etiology and difficult to control. Among lifestyle changes proposed to the treatment of this disease and comorbidities, there is the modulation of dietary lipid composition. This study aimed to evaluate the effects of the modulation of fatty acid (FA) polyunsaturated (PUFA) and monounsaturated (MUFA) in energy expenditure (EE), weight loss, body composition, lipid and glycemic profile, free fatty acids (FFA), glycerol, adiponectin, leptin, blood pressure (BP), feeding behavior and expression of PPARα and PPARγ2 genes in adipose tissue (AT) of obese women. It was conducted a parallel, randomized, controlled, single-blind study with dietary intervention (DI) for 60 days, where 32 women with obesity classes I and II were distributed into three groups: G1 = diet rich in n-3 PUFA and n-6 (n = 10); G2 = MUFA-rich diet (n = 11); and G3 = control (n = 11). For G1 and G2 were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. In order to achieve the desired intake of unsaturated FA, both groups received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner (G1 = mix of virgin olive oil [VOO] and soybean oil [SO], overall of 35.2g to 52.8g / day; G2 = VOO, overall of 35.2g to 50.6 g / day), besides gelatin capsules (G1 = 2 g of fish oil / day; G2 = 1 capsule of 1g of SO / day). G3 was instructed to keep their eating habits and consuming placebos (1 sachet of 2g of SO and 1 capsule of 1g of SO / day).
- Conditions
- Obesity
- Being tested
- Group 1 - diet rich in n-3 and n-6 PUFA, Group 2 - diet rich in MUFA, Group 3 - Placebo group
- Keywords
- obesity, lipids, energy expenditure, gene expression
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - diet rich in n-3 and n-6 PUFADietary supplement
In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.
Group 2 - diet rich in MUFADietary supplement
In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.
Group 3 - Placebo groupDietary supplement
Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - diet rich in n-3 and n-6 PUFA | Experimental | Assigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered.
Group 1 received diet rich in n-3 and n-6 polyunsaturated fatty acids (PUFA). The volunteers were asked to consume daily a mixture of virgin olive oil and soybean oil, totaling 35.2g to 52.8g, and 2 g of fish oil. Receives: Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFA |
| Group 2 - diet rich in MUFA | Experimental | Assigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered.
Group 2 received diet rich in monounsaturated fatty acids (MUFA). The volunteers were asked to consume daily virgin olive oil, totaling 35.2g to 50.6g, and 1 capsule of 1g of soybean oil. Receives: Dietary Supplement: Group 2 - diet rich in MUFA |
| Group 3 - Placebo group | Experimental | Placebo group was instructed to keep their eating habits and consuming 1 sachet of 2g of soybean oil and 1 capsule of 1g of soybean oil by day. Receives: Dietary Supplement: Group 3 - Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women
The energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)
Measured: Change from baseline energy expenditure at 2 months
Secondary outcomes (13)
Effects of modulation of PUFA and MUFA in body weight of obese women
Measured: Change from baseline loss of body weight at 2 months
Effects of modulation of PUFA and MUFA in body composition of obese women
The body composition was evaluated by electrical bioimpedance
Measured: Change from baseline body composition at 2 months
Effects of modulation of PUFA and MUFA in feeding behavior of obese women
Feeding behavior was evaluated by Three Factor Eating Questionnaire
Measured: Change from baseline feeding behavior at 2 months
Effects of modulation of PUFA and MUFA in gene expression of obese women
Gene expression of PPARα and PPARγ2 in adipose tissue
Measured: Change from baseline gene expression at 2 months
Effects of modulation of PUFA and MUFA in blood glucose of obese women
Measured: Change from baseline blood glucose at 2 months
Effects of modulation of PUFA and MUFA in blood insulin of obese women
Measured: Change from baseline blood insulin at 2 months
Effects of modulation of PUFA and MUFA in insulin resistance of obese women
Insulin resistance was evaluated by Homeostasis Model Assessment
Measured: Change from baseline insulin resistance at 2 months
Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women
Insulin resistance was evaluated by Quantitative Insulin Sensitivity Check Index
Measured: Change from baseline insulin sensitivity at 2 months
Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese women
total cholesterol and fractions and triglycerides
Measured: Change from baseline total cholesterol and fractions at 2 months
Effects of modulation of PUFA and MUFA in adiponectin of obese women
serum adiponectin
Measured: Change from baseline adiponectin at 2 months
Effects of modulation of PUFA and MUFA in leptin of obese women
serum leptin
Measured: Change from baseline leptin at 2 months
Effects of modulation of PUFA and MUFA in TNF alpha of obese women
serum TNF alpha
Measured: Change from baseline TNF alpha at 2 months
Effects of modulation of PUFA and MUFA in interleukin 6 of obese women
serum interleukin 6
Measured: Change from baseline interleukin 6 at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Chaia Kaippert, Universidade Federal do Rio de Janeiro
- Investigators
- Eliane L Rosado, Doctor, Study director, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656940
- Sponsor's protocol ID
- 778/10 Parecer CEP
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ailhaud G, Massiera F, Weill P, Legrand P, Alessandri JM, Guesnet P. Temporal changes in dietary fats: role of n-6 polyunsaturated fatty acids in excessive adipose tissue development and relationship to obesity. Prog Lipid Res. 2006 May;45(3):203-36. doi: 10.1016/j.plipres.2006.01.003. Epub 2006 Feb 10.
PubMed 16516300Barson JR, Karatayev O, Gaysinskaya V, Chang GQ, Leibowitz SF. Effect of dietary fatty acid composition on food intake, triglycerides, and hypothalamic peptides. Regul Pept. 2012 Jan 10;173(1-3):13-20. doi: 10.1016/j.regpep.2011.08.012. Epub 2011 Sep 6.
PubMed 21903140Bjermo H, Iggman D, Kullberg J, Dahlman I, Johansson L, Persson L, Berglund J, Pulkki K, Basu S, Uusitupa M, Rudling M, Arner P, Cederholm T, Ahlstrom H, Riserus U. Effects of n-6 PUFAs compared with SFAs on liver fat, lipoproteins, and inflammation in abdominal obesity: a randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1003-12. doi: 10.3945/ajcn.111.030114. Epub 2012 Apr 4.
PubMed 22492369Buckley JD, Howe PR. Anti-obesity effects of long-chain omega-3 polyunsaturated fatty acids. Obes Rev. 2009 Nov;10(6):648-59. doi: 10.1111/j.1467-789X.2009.00584.x. Epub 2009 May 12.
PubMed 19460115Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Gomez-Flores A, Salas-Salvado J. Acute effects of three high-fat meals with different fat saturations on energy expenditure, substrate oxidation and satiety. Clin Nutr. 2009 Feb;28(1):39-45. doi: 10.1016/j.clnu.2008.10.008. Epub 2008 Nov 17.
PubMed 19010571Clarke SD, Gasperikova D, Nelson C, Lapillonne A, Heird WC. Fatty acid regulation of gene expression: a genomic explanation for the benefits of the mediterranean diet. Ann N Y Acad Sci. 2002 Jun;967:283-98.
PubMed 12079856Clevenger HC, Stevenson JL, Cooper JA. Metabolic responses to dietary fatty acids in obese women. Physiol Behav. 2015 Feb;139:73-9. doi: 10.1016/j.physbeh.2014.11.022. Epub 2014 Nov 13.
PubMed 25446217DeFina LF, Marcoux LG, Devers SM, Cleaver JP, Willis BL. Effects of omega-3 supplementation in combination with diet and exercise on weight loss and body composition. Am J Clin Nutr. 2011 Feb;93(2):455-62. doi: 10.3945/ajcn.110.002741. Epub 2010 Dec 15.
PubMed 21159785Flint A, Helt B, Raben A, Toubro S, Astrup A. Effects of different dietary fat types on postprandial appetite and energy expenditure. Obes Res. 2003 Dec;11(12):1449-55. doi: 10.1038/oby.2003.194.
PubMed 14694208Guri AJ, Hontecillas R, Bassaganya-Riera J. Dietary modulators of peroxisome proliferator-activated receptors: implications for the prevention and treatment of metabolic syndrome. J Nutrigenet Nutrigenomics. 2008;1(3):126-35. doi: 10.1159/000112460. Epub 2008 Feb 20.
PubMed 19776622Krebs JD, Browning LM, McLean NK, Rothwell JL, Mishra GD, Moore CS, Jebb SA. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. Int J Obes (Lond). 2006 Oct;30(10):1535-44. doi: 10.1038/sj.ijo.0803309. Epub 2006 Mar 21.
PubMed 16552404Krishnan S, Cooper JA. Effect of dietary fatty acid composition on substrate utilization and body weight maintenance in humans. Eur J Nutr. 2014 Apr;53(3):691-710. doi: 10.1007/s00394-013-0638-z. Epub 2013 Dec 22.
PubMed 24363161Liao FH, Liou TH, Shieh MJ, Chien YW. Effects of different ratios of monounsaturated and polyunsaturated fatty acids to saturated fatty acids on regulating body fat deposition in hamsters. Nutrition. 2010 Jul-Aug;26(7-8):811-7. doi: 10.1016/j.nut.2009.09.009. Epub 2009 Dec 22.
PubMed 20022469Nakamura MT, Yudell BE, Loor JJ. Regulation of energy metabolism by long-chain fatty acids. Prog Lipid Res. 2014 Jan;53:124-44. doi: 10.1016/j.plipres.2013.12.001. Epub 2013 Dec 18.
PubMed 24362249Mejia-Barradas CM, Del-Rio-Navarro BE, Dominguez-Lopez A, Campos-Rodriguez R, Martinez-Godinez Md, Rojas-Hernandez S, Lara-Padilla E, Abarca-Rojano E, Miliar-Garcia A. The consumption of n-3 polyunsaturated fatty acids differentially modulates gene expression of peroxisome proliferator-activated receptor alpha and gamma and hypoxia-inducible factor 1 alpha in subcutaneous adipose tissue of obese adolescents. Endocrine. 2014 Feb;45(1):98-105. doi: 10.1007/s12020-013-9941-y. Epub 2013 Apr 2.
PubMed 23546614
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Lipid Modulation in Energy Expenditure, Body Composition, Obesity-related Biomarkers and Gene Expression of Peroxisome Proliferator-Activated Receptors Alpha and Gamma 2 in Adipose Tissue of Obese Women
- ClinicalTrials.gov ID
- NCT02656940
- Acronym / sponsor ID
- 778/10 Parecer CEP
- Conditions
- Obesity
- Keywords
- obesity, lipids, energy expenditure, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Jan 2016 (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 this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities.
Detailed description
Obesity is a complex disease of multifactorial etiology and difficult to control. Among lifestyle changes proposed to the treatment of this disease and comorbidities, there is the modulation of dietary lipid composition. This study aimed to evaluate the effects of the modulation of fatty acid (FA) polyunsaturated (PUFA) and monounsaturated (MUFA) in energy expenditure (EE), weight loss, body composition, lipid and glycemic profile, free fatty acids (FFA), glycerol, adiponectin, leptin, blood pressure (BP), feeding behavior and expression of PPARα and PPARγ2 genes in adipose tissue (AT) of obese women. It was conducted a parallel, randomized, controlled, single-blind study with dietary intervention (DI) for 60 days, where 32 women with obesity classes I and II were distributed into three groups: G1 = diet rich in n-3 PUFA and n-6 (n = 10); G2 = MUFA-rich diet (n = 11); and G3 = control (n = 11). For G1 and G2 were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. In order to achieve the desired intake of unsaturated FA, both groups received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner (G1 = mix of virgin olive oil [VOO] and soybean oil [SO], overall of 35.2g to 52.8g / day; G2 = VOO, overall of 35.2g to 50.6 g / day), besides gelatin capsules (G1 = 2 g of fish oil / day; G2 = 1 capsule of 1g of SO / day). G3 was instructed to keep their eating habits and consuming placebos (1 sachet of 2g of SO and 1 capsule of 1g of SO / day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - diet rich in n-3 and n-6 PUFA | Experimental | Dietary Supplement: Group 1 - diet rich in n-3 and n-6 PUFAAssigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. Group 1 received diet rich in n-3 and n-6 polyunsaturated fatty acids (PUFA). The volunteers were asked to consume daily a mixture of virgin olive oil and soybean oil, totaling 35.2g to 52.8g, and 2 g of fish oil. |
| Group 2 - diet rich in MUFA | Experimental | Dietary Supplement: Group 2 - diet rich in MUFAAssigned intervention: The dietary intervention was conducted by 60 days. Were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. Group 2 received diet rich in monounsaturated fatty acids (MUFA). The volunteers were asked to consume daily virgin olive oil, totaling 35.2g to 50.6g, and 1 capsule of 1g of soybean oil. |
| Group 3 - Placebo group | Experimental | Dietary Supplement: Group 3 - Placebo groupPlacebo group was instructed to keep their eating habits and consuming 1 sachet of 2g of soybean oil and 1 capsule of 1g of soybean oil by day. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
- completion of basic education (former 4th primary series).
Key exclusion criteria (8 listed)
- menopausal;
- weight loss more than three kilograms (3 kg) in the last three months;
- diagnosis of diabetes mellitus, heart disease, hypertension, nephropathy, liver diseases , thyroid dysfunction; gastrointestinal disorders , acquired immunodeficiency syndrome or cancer;
- cholecystectomy in the past 12 months and other recent surgeries;
- pregnancy or lactation;
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 |
|---|---|---|
| Group 1 - diet rich in n-3 and n-6 PUFAIn order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days. | Dietary supplement | Group 1 - diet rich in n-3 and n-6 PUFA |
| Group 2 - diet rich in MUFAIn order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days. | Dietary supplement | Group 2 - diet rich in MUFA |
| Group 3 - Placebo groupPlacebo group was instructed to keep their eating habits and consuming placebo for 60 days. | Dietary supplement | Group 3 - Placebo group |
Primary outcome
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women
Time frame: Change from baseline energy expenditure at 2 months
The energy expenditure was evaluated by indirect calorimetry (Vmax Encore 29 Systems®)
13 secondary outcomes
Effects of modulation of PUFA and MUFA in body weight of obese women
Time frame: Change from baseline loss of body weight at 2 months
Effects of modulation of PUFA and MUFA in body composition of obese women
Time frame: Change from baseline body composition at 2 months
Effects of modulation of PUFA and MUFA in feeding behavior of obese women
Time frame: Change from baseline feeding behavior at 2 months
Effects of modulation of PUFA and MUFA in gene expression of obese women
Time frame: Change from baseline gene expression at 2 months
Effects of modulation of PUFA and MUFA in blood glucose of obese women
Time frame: Change from baseline blood glucose at 2 months
Effects of modulation of PUFA and MUFA in blood insulin of obese women
Time frame: Change from baseline blood insulin at 2 months
Effects of modulation of PUFA and MUFA in insulin resistance of obese women
Time frame: Change from baseline insulin resistance at 2 months
Effects of modulation of PUFA and MUFA in insulin sensitivity of obese women
Time frame: Change from baseline insulin sensitivity at 2 months
Effects of modulation of PUFA and MUFA in total cholesterol and fractions of obese women
Time frame: Change from baseline total cholesterol and fractions at 2 months
Effects of modulation of PUFA and MUFA in adiponectin of obese women
Time frame: Change from baseline adiponectin at 2 months
Effects of modulation of PUFA and MUFA in leptin of obese women
Time frame: Change from baseline leptin at 2 months
Effects of modulation of PUFA and MUFA in TNF alpha of obese women
Time frame: Change from baseline TNF alpha at 2 months
Effects of modulation of PUFA and MUFA in interleukin 6 of obese women
Time frame: Change from baseline interleukin 6 at 2 months
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 15 Jan 2016.
- Background: PubMed 16516300Ailhaud G, Massiera F, Weill P, Legrand P, Alessandri JM, Guesnet P. Temporal changes in dietary fats: role of n-6 polyunsaturated fatty acids in excessive adipose tissue development and relationship to obesity. Prog Lipid Res. 2006 May;45(3):203-36. doi: 10.1016/j.plipres.2006.01.003. Epub 2006 Feb 10.
- Background: PubMed 21903140Barson JR, Karatayev O, Gaysinskaya V, Chang GQ, Leibowitz SF. Effect of dietary fatty acid composition on food intake, triglycerides, and hypothalamic peptides. Regul Pept. 2012 Jan 10;173(1-3):13-20. doi: 10.1016/j.regpep.2011.08.012. Epub 2011 Sep 6.
- Background: PubMed 22492369Bjermo H, Iggman D, Kullberg J, Dahlman I, Johansson L, Persson L, Berglund J, Pulkki K, Basu S, Uusitupa M, Rudling M, Arner P, Cederholm T, Ahlstrom H, Riserus U. Effects of n-6 PUFAs compared with SFAs on liver fat, lipoproteins, and inflammation in abdominal obesity: a randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1003-12. doi: 10.3945/ajcn.111.030114. Epub 2012 Apr 4.
- Background: PubMed 19460115Buckley JD, Howe PR. Anti-obesity effects of long-chain omega-3 polyunsaturated fatty acids. Obes Rev. 2009 Nov;10(6):648-59. doi: 10.1111/j.1467-789X.2009.00584.x. Epub 2009 May 12.
- Background: PubMed 19010571Casas-Agustench P, Lopez-Uriarte P, Bullo M, Ros E, Gomez-Flores A, Salas-Salvado J. Acute effects of three high-fat meals with different fat saturations on energy expenditure, substrate oxidation and satiety. Clin Nutr. 2009 Feb;28(1):39-45. doi: 10.1016/j.clnu.2008.10.008. Epub 2008 Nov 17.
- Background: PubMed 12079856Clarke SD, Gasperikova D, Nelson C, Lapillonne A, Heird WC. Fatty acid regulation of gene expression: a genomic explanation for the benefits of the mediterranean diet. Ann N Y Acad Sci. 2002 Jun;967:283-98.
- Background: PubMed 25446217Clevenger HC, Stevenson JL, Cooper JA. Metabolic responses to dietary fatty acids in obese women. Physiol Behav. 2015 Feb;139:73-9. doi: 10.1016/j.physbeh.2014.11.022. Epub 2014 Nov 13.
- Background: PubMed 21159785DeFina LF, Marcoux LG, Devers SM, Cleaver JP, Willis BL. Effects of omega-3 supplementation in combination with diet and exercise on weight loss and body composition. Am J Clin Nutr. 2011 Feb;93(2):455-62. doi: 10.3945/ajcn.110.002741. Epub 2010 Dec 15.
- Background: PubMed 14694208Flint A, Helt B, Raben A, Toubro S, Astrup A. Effects of different dietary fat types on postprandial appetite and energy expenditure. Obes Res. 2003 Dec;11(12):1449-55. doi: 10.1038/oby.2003.194.
- Background: PubMed 19776622Guri AJ, Hontecillas R, Bassaganya-Riera J. Dietary modulators of peroxisome proliferator-activated receptors: implications for the prevention and treatment of metabolic syndrome. J Nutrigenet Nutrigenomics. 2008;1(3):126-35. doi: 10.1159/000112460. Epub 2008 Feb 20.
- Background: PubMed 16552404Krebs JD, Browning LM, McLean NK, Rothwell JL, Mishra GD, Moore CS, Jebb SA. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. Int J Obes (Lond). 2006 Oct;30(10):1535-44. doi: 10.1038/sj.ijo.0803309. Epub 2006 Mar 21.
- Background: PubMed 24363161Krishnan S, Cooper JA. Effect of dietary fatty acid composition on substrate utilization and body weight maintenance in humans. Eur J Nutr. 2014 Apr;53(3):691-710. doi: 10.1007/s00394-013-0638-z. Epub 2013 Dec 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.
Eliane L Rosado, Doctor study director
UFRJ
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 - diet rich in n-3 and n-6 PUFA and Group 2 - diet rich in MUFA in people with Obesity, run by Universidade Federal do Rio de Janeiro.
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 2 inclusion and 8 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 15 Jan 2016. 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. 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?
Compare the effects of modulation of PUFA and MUFA in energy expenditure of obese women (time frame: Change from baseline energy expenditure at 2 months). 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 NCT02656940, which also lists 17 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 15 Jan 2016.