Obesity, Inflammation and Aging: Effects of Physical Exercise and Omega-3 Fatty Acids.

NCT03300388 | Completed

• 1 other identifier: OBELEX
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Dysfunction of adipose tissue in obesity, inflammation and aging: mechanisms and effects of physical exercise and omega-3 fatty acids.

Conditions

Obesity; Aging; Inflammation

Keywords

Insulin resistance; Exercise; Omega-3 fatty acids; Adipose tissue

Outcome Measures

Primary Outcomes (2)

• Fat mass reduction

  Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).

  Week 0 (baseline)

• Fat mass reduction

  Evaluation of body fat mass changes induced by the different interventions, analyzed by Dual X-ray Absorptiometry (DXA).

  Week 16 (end of intervention)

Secondary Outcomes (94)

• Evolution of fat mass reduction

  Week 0 (baseline)

• Evolution of fat mass reduction

  Week 2

• Evolution of fat mass reduction

  Week 4

• Evolution of fat mass reduction

  Week 6

• Evolution of fat mass reduction

  Week 8

Study Arms (4)

Control

PLACEBO COMPARATOR

Dietary advice for a healthy diet supplemented with placebo (olive oil).

Dietary Supplement: Placebo (olive oil)

Omega-3

EXPERIMENTAL

Dietary advice for a healthy diet supplemented with DHA-rich dietary supplement (providing 1.650 mg/day of DHA).

Dietary Supplement: Omega-3 (DHA-rich dietary supplement)

Resistance Training

EXPERIMENTAL

Dietary advice for a healthy diet supplemented with placebo (olive oil) and moderate resistance training program.

Dietary Supplement: Placebo (olive oil); Other: Resistance training

Omega-3 + Resistance Training

EXPERIMENTAL

Dietary advice for a healthy diet supplemented with a DHA-rich dietary supplement (providing 1.650 mg/day of DHA) and moderate resistance training program.

Dietary Supplement: Omega-3 (DHA-rich dietary supplement); Other: Resistance training

Interventions

Omega-3 (DHA-rich dietary supplement) DIETARY_SUPPLEMENT

Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.

Omega-3; Omega-3 + Resistance Training

Placebo (olive oil) DIETARY_SUPPLEMENT

Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.

Control; Resistance Training

Resistance training OTHER

Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.

Omega-3 + Resistance Training; Resistance Training

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women
• Age between 55 and 70 years
• Body Mass Index (BMI) between 27.5 and 35 kg/m²
• Weight unchanged (± 3 kg) for the last 3 months
• Overall physical and psychological condition that the investigator believes is in accordance with the overall aim of the study

You may not qualify if:

• Use of regular prescription medication: specially statins, antidiabetic drugs, menopausal hormone replacement therapy
• To suffer from any chronic metabolic condition: severe dislipidemia, type 1 or 2 diabetes, hepatic (cirrhosis), renal disease, cardiovascular disease, neuromuscular disease, arthritic disease, pulmonary disease and/or other debilitating diseases
• Food allergies and/or food intolerance expected to come up during the study
• Following special diets (Atkins, vegetarian, etc.) prior three months the start of the study
• Eating disorders
• Surgically treated obesity
• Alcohol or drug abuse

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Centro de Estudios, Investigación y Medicina del Deporte: collaborator
• Instituto de Investigación Sanitaria de Navarra (IdiSNA): collaborator

Study Sites (1)

Department of Nutrition, Food Science and Physiology. Centre for Nutrition Research.

Pamplona, Navarre, 31008, Spain

Location

Related Publications (21)

• Martinez-Fernandez L, Gonzalez-Muniesa P, Laiglesia LM, Sainz N, Prieto-Hontoria PL, Escote X, Odriozola L, Corrales FJ, Arbones-Mainar JM, Martinez JA, Moreno-Aliaga MJ. Maresin 1 improves insulin sensitivity and attenuates adipose tissue inflammation in ob/ob and diet-induced obese mice. FASEB J. 2017 May;31(5):2135-2145. doi: 10.1096/fj.201600859R. Epub 2017 Feb 10.

  PMID: 28188173 BACKGROUND

• Lopez-Yoldi M, Stanhope KL, Garaulet M, Chen XG, Marcos-Gomez B, Carrasco-Benso MP, Santa Maria EM, Escote X, Lee V, Nunez MV, Medici V, Martinez-Anso E, Sainz N, Huerta AE, Laiglesia LM, Prieto J, Martinez JA, Bustos M, Havel PJ, Moreno-Aliaga MJ. Role of cardiotrophin-1 in the regulation of metabolic circadian rhythms and adipose core clock genes in mice and characterization of 24-h circulating CT-1 profiles in normal-weight and overweight/obese subjects. FASEB J. 2017 Apr;31(4):1639-1649. doi: 10.1096/fj.201600396RR. Epub 2017 Jan 17.

  PMID: 28096235 BACKGROUND

• Laiglesia LM, Lorente-Cebrian S, Prieto-Hontoria PL, Fernandez-Galilea M, Ribeiro SM, Sainz N, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid promotes mitochondrial biogenesis and beige-like features in subcutaneous adipocytes from overweight subjects. J Nutr Biochem. 2016 Nov;37:76-82. doi: 10.1016/j.jnutbio.2016.07.019. Epub 2016 Aug 26.

  PMID: 27637001 BACKGROUND

• Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Escote X, Martinez JA, Moreno-Aliaga MJ. Effects of dietary supplementation with EPA and/or alpha-lipoic acid on adipose tissue transcriptomic profile of healthy overweight/obese women following a hypocaloric diet. Biofactors. 2017 Jan 2;43(1):117-131. doi: 10.1002/biof.1317. Epub 2016 Aug 10.

  PMID: 27507611 BACKGROUND

• Huerta AE, Prieto-Hontoria PL, Sainz N, Martinez JA, Moreno-Aliaga MJ. Supplementation with alpha-Lipoic Acid Alone or in Combination with Eicosapentaenoic Acid Modulates the Inflammatory Status of Healthy Overweight or Obese Women Consuming an Energy-Restricted Diet. J Nutr. 2015 Apr 1;146(4):889S-896S. doi: 10.3945/jn.115.224105.

  PMID: 26962183 BACKGROUND

• Milagro FI, Moreno-Aliaga MJ, Martinez JA. FTO Obesity Variant and Adipocyte Browning in Humans. N Engl J Med. 2016 Jan 14;374(2):190-1. doi: 10.1056/NEJMc1513316. No abstract available.

  PMID: 26760097 BACKGROUND

• Prieto-Hontoria PL, Perez-Matute P, Fernandez-Galilea M, Lopez-Yoldi M, Sinal CJ, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid on chemerin secretion in 3T3-L1 and human adipocytes. Biochim Biophys Acta. 2016 Mar;1861(3):260-8. doi: 10.1016/j.bbalip.2015.12.011. Epub 2015 Dec 22.

  PMID: 26721419 BACKGROUND

• Martinez-Fernandez L, Laiglesia LM, Huerta AE, Martinez JA, Moreno-Aliaga MJ. Omega-3 fatty acids and adipose tissue function in obesity and metabolic syndrome. Prostaglandins Other Lipid Mediat. 2015 Sep;121(Pt A):24-41. doi: 10.1016/j.prostaglandins.2015.07.003. Epub 2015 Jul 26.

  PMID: 26219838 BACKGROUND

• Mansego ML, Milagro FI, Zulet MA, Moreno-Aliaga MJ, Martinez JA. Differential DNA Methylation in Relation to Age and Health Risks of Obesity. Int J Mol Sci. 2015 Jul 24;16(8):16816-32. doi: 10.3390/ijms160816816.

  PMID: 26213922 BACKGROUND

• Huerta AE, Prieto-Hontoria PL, Fernandez-Galilea M, Sainz N, Cuervo M, Martinez JA, Moreno-Aliaga MJ. Circulating irisin and glucose metabolism in overweight/obese women: effects of alpha-lipoic acid and eicosapentaenoic acid. J Physiol Biochem. 2015 Sep;71(3):547-58. doi: 10.1007/s13105-015-0400-5. Epub 2015 Mar 28.

  PMID: 25820474 BACKGROUND

• Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Laiglesia LM, Martinez JA, Moreno-Aliaga MJ. An update on the role of omega-3 fatty acids on inflammatory and degenerative diseases. J Physiol Biochem. 2015 Jun;71(2):341-9. doi: 10.1007/s13105-015-0395-y. Epub 2015 Mar 11.

  PMID: 25752887 BACKGROUND

• Huerta AE, Navas-Carretero S, Prieto-Hontoria PL, Martinez JA, Moreno-Aliaga MJ. Effects of alpha-lipoic acid and eicosapentaenoic acid in overweight and obese women during weight loss. Obesity (Silver Spring). 2015 Feb;23(2):313-21. doi: 10.1002/oby.20966. Epub 2014 Dec 31.

  PMID: 25594166 BACKGROUND

• Gonzalez-Muniesa P, Marrades MP, Martinez JA, Moreno-Aliaga MJ. Differential proinflammatory and oxidative stress response and vulnerability to metabolic syndrome in habitual high-fat young male consumers putatively predisposed by their genetic background. Int J Mol Sci. 2013 Aug 22;14(9):17238-55. doi: 10.3390/ijms140917238.

  PMID: 23975165 BACKGROUND

• Lorente-Cebrian S, Costa AG, Navas-Carretero S, Zabala M, Martinez JA, Moreno-Aliaga MJ. Role of omega-3 fatty acids in obesity, metabolic syndrome, and cardiovascular diseases: a review of the evidence. J Physiol Biochem. 2013 Sep;69(3):633-51. doi: 10.1007/s13105-013-0265-4. Epub 2013 Jun 22.

  PMID: 23794360 BACKGROUND

• Lorente-Cebrian S, Bustos M, Marti A, Fernandez-Galilea M, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid inhibits tumour necrosis factor-alpha-induced lipolysis in murine cultured adipocytes. J Nutr Biochem. 2012 Mar;23(3):218-27. doi: 10.1016/j.jnutbio.2010.11.018. Epub 2011 Apr 14.

  PMID: 21497077 BACKGROUND

• Marrades MP, Gonzalez-Muniesa P, Martinez JA, Moreno-Aliaga MJ. A dysregulation in CES1, APOE and other lipid metabolism-related genes is associated to cardiovascular risk factors linked to obesity. Obes Facts. 2010 Oct;3(5):312-8. doi: 10.1159/000321451. Epub 2010 Oct 15.

  PMID: 20975297 BACKGROUND

• Marrades MP, Gonzalez-Muniesa P, Arteta D, Martinez JA, Moreno-Aliaga MJ. Orchestrated downregulation of genes involved in oxidative metabolic pathways in obese vs. lean high-fat young male consumers. J Physiol Biochem. 2011 Mar;67(1):15-26. doi: 10.1007/s13105-010-0044-4. Epub 2010 Sep 30.

  PMID: 20882379 BACKGROUND

• Moreno-Aliaga MJ, Lorente-Cebrian S, Martinez JA. Regulation of adipokine secretion by n-3 fatty acids. Proc Nutr Soc. 2010 Aug;69(3):324-32. doi: 10.1017/S0029665110001801. Epub 2010 Jun 14.

  PMID: 20540825 BACKGROUND

• Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid up-regulates apelin secretion and gene expression in 3T3-L1 adipocytes. Mol Nutr Food Res. 2010 May;54 Suppl 1:S104-11. doi: 10.1002/mnfr.200900522.

  PMID: 20352620 BACKGROUND

• Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid stimulates AMP-activated protein kinase and increases visfatin secretion in cultured murine adipocytes. Clin Sci (Lond). 2009 Aug 14;117(6):243-9. doi: 10.1042/CS20090020.

  PMID: 19296827 BACKGROUND

• Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Marti A, Martinez JA, Moreno-Aliaga MJ. Down-regulation in muscle and liver lipogenic genes: EPA ethyl ester treatment in lean and overweight (high-fat-fed) rats. J Nutr Biochem. 2009 Sep;20(9):705-14. doi: 10.1016/j.jnutbio.2008.06.013. Epub 2008 Sep 30.

  PMID: 18829285 BACKGROUND

Related Links

• Centre for Nutrition Research. University of Navarra
• Department of Nutrition, Food Science and Physiology. University of Navarra

MeSH Terms

Conditions

Obesity; Inflammation; Insulin Resistance; Motor Activity

Interventions

Docosahexaenoic Acids; Olive Oil; Resistance Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• María J Moreno-Aliaga, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• Silvia Lorente-Cebrián, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: October 3, 2017
• Study Start: August 21, 2017
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: November 30, 2020

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)