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CompletedNCT03300388OBELEXUpdated Nov 30, 2020

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

An interventional study of Omega-3 (DHA-rich dietary supplement) and Placebo (olive oil) in Obesity, Aging and Inflammation, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to female participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-30.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
55 Years to 70 Years
Sex
Female
01

Study summary

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

Read the detailed description

Obesity is associated with the development of metabolic diseases including type 2 diabetes and immune disorders. Obesity also leads to reduced lifespan and accelerated cellular processes similar to those of aging. On the other hand, aging is accompanied by the accumulation of visceral fat and the metabolic complications associated to obesity. Both obesity and aging have been identified as chronic, low-grade inflammation disorders. The inflammation in aging has been considered as a risk factor for the development of most of age-related diseases, and therefore for morbidity and mortality in the elderly. However, the specific mechanisms leading to inflammation in aging remain largely unknown.

Resolution of inflammation is an active process which involves production of several series of specialized pro-resolving lipid mediators such lipoxins, resolvin, protectins and maresin. The hypothesis of this trial is that the chronic inflammation associated to obesity and aging could be the result of an impaired production of these specialized pro-resolutive lipid mediators, mainly in adipose tissue. On the other hand, the investigators also propose that altered transcriptional pattern might be responsible for the development of the inflammation associated with the pathophysiology of obesity and aging. Therefore the first general aim of the current project will be to characterize the mechanisms involved in the unresolved chronic inflammation that arises during obesity and aging.

Because n-3 PUFAs (polyunsaturated fatty acids) serve as substrates for the synthesis of specialized pro-resolving lipid mediators and are important transcriptional regulators, the investigators propose that dietary supplementation with n-3 PUFAs, alone or in combination with regular physical exercise could promote the resolution of local and systemic inflammation and the subsequent metabolic disorders associated to obesity and aging. A trial in overweight/obese postmenopausal women will be carried out to characterize the potential beneficial effects of regular administration of a DHA-rich dietary supplement and/or a progressive resistance training (PRT) program on weight and fat mass loss, insulin sensitivity, inflammatory markers and gene/miRNA/lipidomic/metabolomic profile in serum and/or adipose tissue. Moreover, changes in gut microbiota will be also addressed.

02

Conditions studied

  • Obesity
  • Aging
  • Inflammation

Keywords

  • Insulin resistance
  • Exercise
  • Omega-3 fatty acids
  • Adipose tissue
03

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
85 participants (actual)

Study arms

  • Placebo comparator
    Control

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

    Dietary Supplement: Placebo (olive oil)

  • Experimental
    Omega-3

    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)

  • Experimental
    Resistance Training

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

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

  • Experimental
    Omega-3 + Resistance Training

    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

  • Dietary supplementOmega-3 (DHA-rich dietary supplement)

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

  • Dietary supplementPlacebo (olive oil)

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

  • OtherResistance training

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

05

What researchers measure

Primary outcomes

  1. Fat mass reduction

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

    Time frame: Week 0 (baseline)

  2. Fat mass reduction

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

    Time frame: Week 16 (end of intervention)

Secondary outcomes

  1. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 0 (baseline)

  2. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 2

  3. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 4

  4. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 6

  5. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 8

  6. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 10

  7. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 12

  8. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 14

  9. Evolution of fat mass reduction

    Evaluation of body fat mass changes induced by the different interventions analyzed by bioimpedance.

    Time frame: Week 16 (end of intervention)

  10. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 0 (baseline)

  11. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 2

  12. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 4

  13. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 6

  14. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 8

  15. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 10

  16. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 12

  17. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 14

  18. Weight loss

    Changes in body weight will be measured by a body weight scale to the nearest 0.1 kg

    Time frame: Week 16 (end of intervention)

  19. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 0 (baseline)

  20. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 2

  21. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 4

  22. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 6

  23. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 8

  24. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 10

  25. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 12

  26. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 14

  27. Evolution of body composition

    Evaluation of fat-free mass changes will be analyzed by bioimpedance.

    Time frame: Week 16 (end of intervention)

  28. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  29. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Time frame: Week 8

  30. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  31. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  32. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Time frame: Week 8

  33. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  34. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  35. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Time frame: Week 8

  36. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  37. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  38. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Time frame: Week 8

  39. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  40. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  41. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Time frame: Week 8

  42. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  43. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  44. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Time frame: Week 8

  45. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  46. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Time frame: Week 0 (baseline)

  47. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Time frame: Week 8

  48. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Time frame: Week 16 (end of intervention)

  49. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Time frame: Week 0 (baseline)

  50. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Time frame: Week 8

  51. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Time frame: Week 16 (end of intervention)

  52. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Time frame: Week 0 (baseline)

  53. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Time frame: Week 8

  54. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Time frame: Week 16 (end of intervention)

  55. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Time frame: Week 0 (baseline)

  56. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Time frame: Week 8

  57. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Time frame: Week 16 (end of intervention)

  58. Blood pressure

    Systolic and diastolic blood pressure will be measured with a tensiometer.

    Time frame: Week 0 (baseline)

  59. Blood pressure

    Systolic and diastolic blood pressure will be measured with a tensiometer.

    Time frame: Week 8

  60. Blood pressure

    Systolic and diastolic blood pressure will be measured with a tensiometer.

    Time frame: Week 16 (end of intervention)

  61. Serum glucose

    Fasting serum glucose will be measured after overnight fast.

    Time frame: Week 0 (baseline)

  62. Serum glucose

    Fasting serum glucose will be measured after overnight fast.

    Time frame: Week 16 (end of intervention)

  63. Serum insulin

    Fasting serum insulin will be measured after overnight fast.

    Time frame: Week 0 (baseline)

  64. Serum insulin

    Fasting serum insulin will be measured after overnight fast.

    Time frame: Week 16 (end of intervention)

  65. Oral Glucose Tolerance Test

    Oral Glucose Tolerance Test will be carried out after overnight fast.

    Time frame: Week 0 (baseline)

  66. Oral Glucose Tolerance Test

    Oral Glucose Tolerance Test will be carried out after overnight fast.

    Time frame: Week 16 (end of intervention)

  67. Lipid metabolism biomarkers

    Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.

    Time frame: Week 0 (baseline)

  68. Lipid metabolism biomarkers

    Serum free fatty acids, triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol concentrations will be measured after an overnight fast.

    Time frame: Week 16 (end of intervention)

  69. Ketone bodies

    Ketone bodies concentrations will be measured after an overnight fast.

    Time frame: Week 0 (baseline)

  70. Ketone bodies

    Ketone bodies concentrations will be measured after an overnight fast.

    Time frame: Week 16 (end of intervention)

  71. Thyroid function (body metabolism)

    TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits

    Time frame: Week 0 (baseline)

  72. Thyroid function (body metabolism)

    TSH (thyroid-stimulating hormone), T3 and T4 hormones will be evaluated with ELISA kits

    Time frame: Week 16 (end of intervention)

  73. Cardiovascular risk biomarkers

    PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits

    Time frame: Week 0 (baseline)

  74. Cardiovascular risk biomarkers

    PAI-1 (plasminogen activator inhibitor-1), ADMA (asymmetric dimethylarginine) and VEGF (vascular endothelial growth factor) will be measured in plasma using ELISA kits

    Time frame: Week 16 (end of intervention)

  75. Inflammation biomarkers

    TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured by ELISA kits

    Time frame: Week 0 (baseline)

  76. Inflammation biomarkers

    TNF-α (tumour necrosis factor-alpha), IL-6 (interleukin 6), C-reactive protein, serum A-amyloid, leptin, adiponectin, chemerin will be measured in plasma by ELISA kits

    Time frame: Week 16 (end of intervention)

  77. Satiety and eating behavior traits

    Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires

    Time frame: Week 0 (baseline)

  78. Satiety and eating behavior traits

    Satiety will be also estimated by using a VAS (visual analogue scale) questionnaire and eating behavior traits will be also evaluated with validated questionnaires

    Time frame: Week 16 (end of intervention)

  79. Plasma adipokines and myo-kines

    CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits

    Time frame: Week 0 (baseline)

  80. Plasma adipokines and myo-kines

    CT-1, irisin, FGF21 (fibroblast growth factor 21) and meteorin-like will be measured using ELISA kits

    Time frame: Week 16 (end of intervention)

  81. Plasma lipids and bioactive lipid mediators

    Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).

    Time frame: Week 0 (baseline)

  82. Plasma lipids and bioactive lipid mediators

    Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS (high pressure liquid chromatography-mass spectrometry).

    Time frame: Week 16 (end of intervention)

  83. Adipose tissue gene profiling

    A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).

    Time frame: Week 0 (baseline)

  84. Adipose tissue gene profiling

    A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained by liposuction under local anesthesia. RNA expression will be measured by RNA-seq or GeneChip Human Gene 2.1 ST Array (Affymetrix).

    Time frame: Week 16 (end of intervention)

  85. Adipose tissue miRNA profiling

    MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.

    Time frame: Week 0 (baseline)

  86. Adipose tissue miRNA profiling

    MiRNA expression will be measured by RNA-seq or GeneChip miRNA 4.0 Array (Affymetrix) in subcutaneous abdominal adipose tissue biopsies.

    Time frame: Week 16 (end of intervention)

  87. Bioactive lipid mediators involved in inflammation in adipose tissue

    Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS

    Time frame: Week 0 (baseline)

  88. Bioactive lipid mediators involved in inflammation in adipose tissue

    Lipidomic profile will be measured using targeted metabolomic-lipidomics by HPLC-MS

    Time frame: Week 16 (end of intervention)

  89. Determination of telomeres length

    Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.

    Time frame: Week 0 (baseline)

  90. Determination of telomeres length

    Telomeres length will be measured in genomic DNA extracted from human peripheral blood and adipose tissue samples with a real-time quantitative PCR (polymerase chain reaction) approach.

    Time frame: Week 16 (end of intervention)

  91. Characterization of gut microbiota

    Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.

    Time frame: Week 0 (baseline)

  92. Characterization of gut microbiota

    Feces will collected and gut microbiota profiling will be carried out by high-throughput 16S (Svedberg units) rDNA (ribosomal deoxyribonucleic acid) amplicon sequencing approach.

    Time frame: Week 16 (end of intervention)

  93. Urine metabolomic profile

    Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.

    Time frame: Week 0 (baseline)

  94. Urine metabolomic profile

    Urine will be collected and urinary metabolomic profile will be also evaluated by a HPLC-MS approach.

    Time frame: Week 16 (end of intervention)

06

Study locations

1 site
  • Department of Nutrition, Food Science and Physiology. Centre for Nutrition Research.
    Pamplona, Navarra 31008, Spain
07

References and documents

Publications

  • 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. PubMed 28188173 ↗
  • 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. PubMed 28096235 ↗
  • 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. PubMed 27637001 ↗
  • 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. PubMed 27507611 ↗
  • 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. PubMed 26962183 ↗
  • 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. PubMed 26760097 ↗
  • 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. PubMed 26721419 ↗
  • 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. PubMed 26219838 ↗
  • 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. PubMed 26213922 ↗
  • 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. PubMed 25820474 ↗
  • 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. PubMed 25752887 ↗
  • 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. PubMed 25594166 ↗
  • 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. PubMed 23975165 ↗
  • 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. PubMed 23794360 ↗
  • 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. PubMed 21497077 ↗
  • 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. PubMed 20975297 ↗
  • 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. PubMed 20882379 ↗
  • 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. PubMed 20540825 ↗
  • 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. PubMed 20352620 ↗
  • 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. PubMed 19296827 ↗
  • 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. PubMed 18829285 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03300388
Lead sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
Ministerio de Economía y Competitividad, Spain, Centro de Estudios, Investigación y Medicina del Deporte, Instituto de Investigación Sanitaria de Navarra (IdiSNA)
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Aug 21, 2017
Primary completion
Jun 13, 2019
Completion
Jun 13, 2019
Last update
Nov 30, 2020

Study contacts

María J Moreno-Aliaga, PhD
principal investigator · University of Navarra
Silvia Lorente-Cebrián, PhD
principal investigator · University of Navarra

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Clinica Universidad de Navarra, Universidad de Navarra

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