AzTrials
AzTrials

ObesityOBELEXNCT03300388

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

A study testing Omega-3 (DHA-rich dietary supplement) and Resistance training in people with Obesity and Aging, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 55 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Aging, Inflammation
What is being tested?
Omega-3 (DHA-rich dietary supplement) and Resistance training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
1 siteSpain
Study dates
21 Aug 2017to 13 Jun 2019
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 55 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Dysfunction of Adipose Tissue in Obesity, Inflammation and Aging: Mechanisms and 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.

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.

Being tested
Omega-3 (DHA-rich dietary supplement), Placebo (olive oil), Resistance training
Keywords
Insulin resistance, Exercise, Omega-3 fatty acids, Adipose tissue
Medical subject headings
Obesity, Inflammation, Insulin Resistance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 trainingOther

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

Study groups in NCT03300388
Study groupRoleWhat they receive
ControlPlacebo comparatorDietary advice for a healthy diet supplemented with placebo (olive oil).
Receives: Dietary Supplement: Placebo (olive oil)
Omega-3ExperimentalDietary advice for a healthy diet supplemented with DHA-rich dietary supplement (providing 1.650 mg/day of DHA).
Receives: Dietary Supplement: Omega-3 (DHA-rich dietary supplement)
Resistance TrainingExperimentalDietary advice for a healthy diet supplemented with placebo (olive oil) and moderate resistance training program.
Receives: Dietary Supplement: Placebo (olive oil); Other: Resistance training
Omega-3 + Resistance TrainingExperimentalDietary advice for a healthy diet supplemented with a DHA-rich dietary supplement (providing 1.650 mg/day of DHA) and moderate resistance training program.
Receives: Dietary Supplement: Omega-3 (DHA-rich dietary supplement); Other: Resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat mass reduction

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

    Measured: 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).

    Measured: Week 16 (end of intervention)

Secondary outcomes (94)

  1. Evolution of fat mass reduction

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

    Measured: Week 0 (baseline)

  2. Evolution of fat mass reduction

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

    Measured: Week 2

  3. Evolution of fat mass reduction

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

    Measured: Week 4

  4. Evolution of fat mass reduction

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

    Measured: Week 6

  5. Evolution of fat mass reduction

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

    Measured: Week 8

  6. Evolution of fat mass reduction

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

    Measured: Week 10

  7. Evolution of fat mass reduction

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

    Measured: Week 12

  8. Evolution of fat mass reduction

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

    Measured: Week 14

  9. Evolution of fat mass reduction

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

    Measured: 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

    Measured: Week 0 (baseline)

  11. Weight loss

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

    Measured: Week 2

  12. Weight loss

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

    Measured: Week 4

  13. Weight loss

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

    Measured: Week 6

  14. Weight loss

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

    Measured: Week 8

  15. Weight loss

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

    Measured: Week 10

  16. Weight loss

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

    Measured: Week 12

  17. Weight loss

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

    Measured: Week 14

  18. Weight loss

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

    Measured: Week 16 (end of intervention)

  19. Evolution of body composition

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

    Measured: Week 0 (baseline)

  20. Evolution of body composition

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

    Measured: Week 2

  21. Evolution of body composition

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

    Measured: Week 4

  22. Evolution of body composition

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

    Measured: Week 6

  23. Evolution of body composition

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

    Measured: Week 8

  24. Evolution of body composition

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

    Measured: Week 10

  25. Evolution of body composition

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

    Measured: Week 12

  26. Evolution of body composition

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

    Measured: Week 14

  27. Evolution of body composition

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

    Measured: Week 16 (end of intervention)

  28. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  29. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Measured: Week 8

  30. Hip circumference

    Hip circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  31. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  32. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Measured: Week 8

  33. Neck circumference

    Neck circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  34. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  35. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Measured: Week 8

  36. Waist circumference

    Waist circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  37. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  38. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Measured: Week 8

  39. Abdomen circumference

    Abdomen circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  40. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  41. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Measured: Week 8

  42. Arm circumference

    Arm circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  43. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  44. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Measured: Week 8

  45. Midthigh circumference

    Midthigh circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  46. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Measured: Week 0 (baseline)

  47. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Measured: Week 8

  48. Midcalf circumference

    Midcalf circumference will be measured with a measuring tape.

    Measured: Week 16 (end of intervention)

  49. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Measured: Week 0 (baseline)

  50. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Measured: Week 8

  51. Triceps skinfold

    Triceps skinfold will be measured with a caliper.

    Measured: Week 16 (end of intervention)

  52. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Measured: Week 0 (baseline)

  53. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Measured: Week 8

  54. Thigh skinfold

    Thigh skinfold will be measured with a caliper.

    Measured: Week 16 (end of intervention)

  55. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Measured: Week 0 (baseline)

  56. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Measured: Week 8

  57. Medial calf skinfold

    Medial calf skinfold will be measured with a caliper.

    Measured: Week 16 (end of intervention)

  58. Blood pressure

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

    Measured: Week 0 (baseline)

  59. Blood pressure

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

    Measured: Week 8

  60. Blood pressure

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

    Measured: Week 16 (end of intervention)

  61. Serum glucose

    Fasting serum glucose will be measured after overnight fast.

    Measured: Week 0 (baseline)

  62. Serum glucose

    Fasting serum glucose will be measured after overnight fast.

    Measured: Week 16 (end of intervention)

  63. Serum insulin

    Fasting serum insulin will be measured after overnight fast.

    Measured: Week 0 (baseline)

  64. Serum insulin

    Fasting serum insulin will be measured after overnight fast.

    Measured: Week 16 (end of intervention)

  65. Oral Glucose Tolerance Test

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

    Measured: Week 0 (baseline)

  66. Oral Glucose Tolerance Test

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

    Measured: 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.

    Measured: 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.

    Measured: Week 16 (end of intervention)

  69. Ketone bodies

    Ketone bodies concentrations will be measured after an overnight fast.

    Measured: Week 0 (baseline)

  70. Ketone bodies

    Ketone bodies concentrations will be measured after an overnight fast.

    Measured: Week 16 (end of intervention)

  71. Thyroid function (body metabolism)

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

    Measured: Week 0 (baseline)

  72. Thyroid function (body metabolism)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Week 0 (baseline)

  94. Urine metabolomic profile

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

    Measured: Week 16 (end of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start21 Aug 2017
  3. Primary completion13 Jun 2019
  4. Study completion13 Jun 2019

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300388
Sponsor's protocol ID
OBELEX
Acronym
OBELEX
Status last verified
Mar 2017
First submitted
7 Aug 2017
Last updated
30 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Omega-3 (DHA-rich dietary supplement) and Resistance training in people with Obesity and Aging, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

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 5 inclusion and 7 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Fat mass reduction (time frame: Week 0 (baseline)). The study lists 2 primary outcomes in all. 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 NCT03300388, which also lists 21 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 30 Nov 2020.

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