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Completed

NCT Number: NCT03300388

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

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

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Key information

Conditions

Obesity Aging Behavior Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Pamplona, Navarre, 31008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

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.

Resistance training

Other

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

Primary outcomes

  1. Fat mass reduction

    Time frame: Week 0 (baseline)

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

  2. Fat mass reduction

    Time frame: Week 16 (end of intervention)

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

Secondary outcomes

  1. Evolution of fat mass reduction

    Time frame: Week 0 (baseline)

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

  2. Evolution of fat mass reduction

    Time frame: Week 2

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

  3. Evolution of fat mass reduction

    Time frame: Week 4

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

  4. Evolution of fat mass reduction

    Time frame: Week 6

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

  5. Evolution of fat mass reduction

    Time frame: Week 8

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

  6. Evolution of fat mass reduction

    Time frame: Week 10

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

  7. Evolution of fat mass reduction

    Time frame: Week 12

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

  8. Evolution of fat mass reduction

    Time frame: Week 14

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

  9. Evolution of fat mass reduction

    Time frame: Week 16 (end of intervention)

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

  10. Weight loss

    Time frame: Week 0 (baseline)

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

  11. Weight loss

    Time frame: Week 2

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

  12. Weight loss

    Time frame: Week 4

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

  13. Weight loss

    Time frame: Week 6

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

  14. Weight loss

    Time frame: Week 8

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

  15. Weight loss

    Time frame: Week 10

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

  16. Weight loss

    Time frame: Week 12

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

  17. Weight loss

    Time frame: Week 14

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

  18. Weight loss

    Time frame: Week 16 (end of intervention)

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

  19. Evolution of body composition

    Time frame: Week 0 (baseline)

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

  20. Evolution of body composition

    Time frame: Week 2

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

  21. Evolution of body composition

    Time frame: Week 4

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

  22. Evolution of body composition

    Time frame: Week 6

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

  23. Evolution of body composition

    Time frame: Week 8

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

  24. Evolution of body composition

    Time frame: Week 10

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

  25. Evolution of body composition

    Time frame: Week 12

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

  26. Evolution of body composition

    Time frame: Week 14

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

  27. Evolution of body composition

    Time frame: Week 16 (end of intervention)

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

  28. Hip circumference

    Time frame: Week 0 (baseline)

    Hip circumference will be measured with a measuring tape.

  29. Hip circumference

    Time frame: Week 8

    Hip circumference will be measured with a measuring tape.

  30. Hip circumference

    Time frame: Week 16 (end of intervention)

    Hip circumference will be measured with a measuring tape.

  31. Neck circumference

    Time frame: Week 0 (baseline)

    Neck circumference will be measured with a measuring tape.

  32. Neck circumference

    Time frame: Week 8

    Neck circumference will be measured with a measuring tape.

  33. Neck circumference

    Time frame: Week 16 (end of intervention)

    Neck circumference will be measured with a measuring tape.

  34. Waist circumference

    Time frame: Week 0 (baseline)

    Waist circumference will be measured with a measuring tape.

  35. Waist circumference

    Time frame: Week 8

    Waist circumference will be measured with a measuring tape.

  36. Waist circumference

    Time frame: Week 16 (end of intervention)

    Waist circumference will be measured with a measuring tape.

  37. Abdomen circumference

    Time frame: Week 0 (baseline)

    Abdomen circumference will be measured with a measuring tape.

  38. Abdomen circumference

    Time frame: Week 8

    Abdomen circumference will be measured with a measuring tape.

  39. Abdomen circumference

    Time frame: Week 16 (end of intervention)

    Abdomen circumference will be measured with a measuring tape.

  40. Arm circumference

    Time frame: Week 0 (baseline)

    Arm circumference will be measured with a measuring tape.

  41. Arm circumference

    Time frame: Week 8

    Arm circumference will be measured with a measuring tape.

  42. Arm circumference

    Time frame: Week 16 (end of intervention)

    Arm circumference will be measured with a measuring tape.

  43. Midthigh circumference

    Time frame: Week 0 (baseline)

    Midthigh circumference will be measured with a measuring tape.

  44. Midthigh circumference

    Time frame: Week 8

    Midthigh circumference will be measured with a measuring tape.

  45. Midthigh circumference

    Time frame: Week 16 (end of intervention)

    Midthigh circumference will be measured with a measuring tape.

  46. Midcalf circumference

    Time frame: Week 0 (baseline)

    Midcalf circumference will be measured with a measuring tape.

  47. Midcalf circumference

    Time frame: Week 8

    Midcalf circumference will be measured with a measuring tape.

  48. Midcalf circumference

    Time frame: Week 16 (end of intervention)

    Midcalf circumference will be measured with a measuring tape.

  49. Triceps skinfold

    Time frame: Week 0 (baseline)

    Triceps skinfold will be measured with a caliper.

  50. Triceps skinfold

    Time frame: Week 8

    Triceps skinfold will be measured with a caliper.

  51. Triceps skinfold

    Time frame: Week 16 (end of intervention)

    Triceps skinfold will be measured with a caliper.

  52. Thigh skinfold

    Time frame: Week 0 (baseline)

    Thigh skinfold will be measured with a caliper.

  53. Thigh skinfold

    Time frame: Week 8

    Thigh skinfold will be measured with a caliper.

  54. Thigh skinfold

    Time frame: Week 16 (end of intervention)

    Thigh skinfold will be measured with a caliper.

  55. Medial calf skinfold

    Time frame: Week 0 (baseline)

    Medial calf skinfold will be measured with a caliper.

  56. Medial calf skinfold

    Time frame: Week 8

    Medial calf skinfold will be measured with a caliper.

  57. Medial calf skinfold

    Time frame: Week 16 (end of intervention)

    Medial calf skinfold will be measured with a caliper.

  58. Blood pressure

    Time frame: Week 0 (baseline)

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

  59. Blood pressure

    Time frame: Week 8

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

  60. Blood pressure

    Time frame: Week 16 (end of intervention)

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

  61. Serum glucose

    Time frame: Week 0 (baseline)

    Fasting serum glucose will be measured after overnight fast.

  62. Serum glucose

    Time frame: Week 16 (end of intervention)

    Fasting serum glucose will be measured after overnight fast.

  63. Serum insulin

    Time frame: Week 0 (baseline)

    Fasting serum insulin will be measured after overnight fast.

  64. Serum insulin

    Time frame: Week 16 (end of intervention)

    Fasting serum insulin will be measured after overnight fast.

  65. Oral Glucose Tolerance Test

    Time frame: Week 0 (baseline)

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

  66. Oral Glucose Tolerance Test

    Time frame: Week 16 (end of intervention)

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

  67. Lipid metabolism biomarkers

    Time frame: Week 0 (baseline)

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

  68. Lipid metabolism biomarkers

    Time frame: Week 16 (end of intervention)

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

  69. Ketone bodies

    Time frame: Week 0 (baseline)

    Ketone bodies concentrations will be measured after an overnight fast.

  70. Ketone bodies

    Time frame: Week 16 (end of intervention)

    Ketone bodies concentrations will be measured after an overnight fast.

  71. Thyroid function (body metabolism)

    Time frame: Week 0 (baseline)

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

  72. Thyroid function (body metabolism)

    Time frame: Week 16 (end of intervention)

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

  73. Cardiovascular risk biomarkers

    Time frame: Week 0 (baseline)

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

  74. Cardiovascular risk biomarkers

    Time frame: Week 16 (end of intervention)

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

  75. Inflammation biomarkers

    Time frame: Week 0 (baseline)

    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

  76. Inflammation biomarkers

    Time frame: Week 16 (end of intervention)

    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

  77. Satiety and eating behavior traits

    Time frame: Week 0 (baseline)

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

  78. Satiety and eating behavior traits

    Time frame: Week 16 (end of intervention)

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

  79. Plasma adipokines and myo-kines

    Time frame: Week 0 (baseline)

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

  80. Plasma adipokines and myo-kines

    Time frame: Week 16 (end of intervention)

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

  81. Plasma lipids and bioactive lipid mediators

    Time frame: Week 0 (baseline)

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

  82. Plasma lipids and bioactive lipid mediators

    Time frame: Week 16 (end of intervention)

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

  83. Adipose tissue gene profiling

    Time frame: Week 0 (baseline)

    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).

  84. Adipose tissue gene profiling

    Time frame: Week 16 (end of intervention)

    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).

  85. Adipose tissue miRNA profiling

    Time frame: Week 0 (baseline)

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

  86. Adipose tissue miRNA profiling

    Time frame: Week 16 (end of intervention)

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

  87. Bioactive lipid mediators involved in inflammation in adipose tissue

    Time frame: Week 0 (baseline)

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

  88. Bioactive lipid mediators involved in inflammation in adipose tissue

    Time frame: Week 16 (end of intervention)

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

  89. Determination of telomeres length

    Time frame: Week 0 (baseline)

    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.

  90. Determination of telomeres length

    Time frame: Week 16 (end of intervention)

    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.

  91. Characterization of gut microbiota

    Time frame: Week 0 (baseline)

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

  92. Characterization of gut microbiota

    Time frame: Week 16 (end of intervention)

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

  93. Urine metabolomic profile

    Time frame: Week 0 (baseline)

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

  94. Urine metabolomic profile

    Time frame: Week 16 (end of intervention)

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

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Centro de Estudios, Investigación y Medicina del Deporte
  • Fundación Instituto de Investigación Sanitaria de Navarra
  • Ministerio de Economía y Competitividad, Spain

Registry information

Official study title

Dysfunction of Adipose Tissue in Obesity, Inflammation and Aging: Mechanisms and Effects of Physical Exercise and Omega-3 Fatty Acids.

Acronym: OBELEX

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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