Dietary Lipids, Energy Expenditure and Obesity Biomarkers

NCT02656940 | Completed

• 1 other identifier: 778/10 Parecer CEP
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities.

Conditions

Obesity

Keywords

obesity; lipids; energy expenditure; gene expression

Outcome Measures

Primary Outcomes (1)

• 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®)

  Change from baseline energy expenditure at 2 months

Secondary Outcomes (13)

• Effects of modulation of PUFA and MUFA in body weight of obese women

  Change from baseline loss of body weight at 2 months

• Effects of modulation of PUFA and MUFA in body composition of obese women

  Change from baseline body composition at 2 months

• Effects of modulation of PUFA and MUFA in feeding behavior of obese women

  Change from baseline feeding behavior at 2 months

• Effects of modulation of PUFA and MUFA in gene expression of obese women

  Change from baseline gene expression at 2 months

• Effects of modulation of PUFA and MUFA in blood glucose of obese women

  Change from baseline blood glucose at 2 months

Study Arms (3)

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.

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.

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.

Dietary Supplement: Group 3 - Placebo group

Interventions

Group 1 - diet rich in n-3 and n-6 PUFA DIETARY_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 1 - diet rich in n-3 and n-6 PUFA

Group 2 - diet rich in MUFA DIETARY_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 MUFA

Group 3 - Placebo group DIETARY_SUPPLEMENT

Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.

Group 3 - Placebo group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
• completion of basic education (former 4th primary series).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Related Publications (17)

• 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.

  PMID: 16516300 BACKGROUND

• Barson 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.

  PMID: 21903140 BACKGROUND

• Bjermo 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.

  PMID: 22492369 BACKGROUND

• Buckley 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.

  PMID: 19460115 BACKGROUND

• Casas-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.

  PMID: 19010571 BACKGROUND

• Clarke 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.

  PMID: 12079856 BACKGROUND

• Clevenger 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.

  PMID: 25446217 BACKGROUND

• DeFina 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.

  PMID: 21159785 BACKGROUND

• Flint 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.

  PMID: 14694208 BACKGROUND

• Guri 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.

  PMID: 19776622 BACKGROUND

• Krebs 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.

  PMID: 16552404 BACKGROUND

• Krishnan 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.

  PMID: 24363161 BACKGROUND

• Liao 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.

  PMID: 20022469 BACKGROUND

• Nakamura 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.

  PMID: 24362249 BACKGROUND

• Mejia-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.

  PMID: 23546614 BACKGROUND

• van Dijk SJ, Feskens EJ, Bos MB, Hoelen DW, Heijligenberg R, Bromhaar MG, de Groot LC, de Vries JH, Muller M, Afman LA. A saturated fatty acid-rich diet induces an obesity-linked proinflammatory gene expression profile in adipose tissue of subjects at risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1656-64. doi: 10.3945/ajcn.2009.27792. Epub 2009 Oct 14.

  PMID: 19828712 BACKGROUND

• Lopes MCODS, Kaippert VC, Crovesy L, de Carvalho DP, Rosado EL. Monounsaturated fat-rich diet reduces body adiposity in women with obesity, but does not influence energy expenditure and substrate oxidation: a parallel randomized controlled clinical trial. Eur J Clin Nutr. 2024 Apr;78(4):335-343. doi: 10.1038/s41430-024-01401-3. Epub 2024 Jan 12.

  PMID: 38216647 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Fatty Acids, Monounsaturated

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Eliane L Rosado, Doctor

  UFRJ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 15, 2016
• Study Start: February 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 15, 2016

Record last verified: 2016-01