Overweight and Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Participants are randomly assigned to one of two equal groups:
1. High-volume physical exercise intervention with a minimum of 14 hours of supervised brisk walk per week, combined with a low-calorie
Sponsors
Ministry of Economy and Competitiveness (Ministerio de Economía y Competitividad)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years 2. Body mass index = 27 and < 35 Kg/m2 3. Steady body mass, with a fluctuation below 3% during the past six months 4. Non-smoker or smoking < 6 cigarettes per day
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to give written informed consent or communicate with study staff 2. Inability to attend the scheduled visits (lack of autonomy, lack of a permanent address, travel plans, or other reasons) 3. Impossibility to follow the recommended diet (for religious reasons, swallowing disorders, allergies, or other reasons) 4. Body weight loss > 3% of their body weight during the six months preceding the screening visit. 5. History of very-low-caloric diet during the six months before the screening visit 6. Intention to undergo bariatric surgery in the next six months 7. Prior bariatric surgery 8. Obesity of known endocrine origin 9. Cardiovascular disease including angina, myocardial infarction, coronary revascularization procedures, stroke (either ischemic or haemorrhagic, including transient ischemic attacks), symptomatic peripheral artery disease, ventricular arrhythmia, uncontrolled atrial fibrillation, congestive heart failure, hypertrophic cardiomyopathy, history of aortic aneurism, and pacemaker carriers 10. Major surgery (i.e., surgery requiring hospitalization) during the last twelve months 11. Active cancer or history of malignancy within the last five years (except non-melanoma skin cancer or differentiated thyroid cancer) 12. History of inflammatory bowel disease or small bowel resection 13. Liver cirrhosis or chronic renal failure stages 3B, 4 and 5 14. Immunodeficiency or HIV-positive status 15. Psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression with hospitalization in past six months 16. History of major organ transplantation 17. Current treatment with systemic corticosteroids, immunosuppressive drugs or cytotoxic agents 18. History in the past six months or current use of weight loss medication, specifically glucagon-like receptor agonist or inhibitors of sodium–glucose cotransporters. The use of metformin in stable dosage is allowed 19. Respiratory insufficiency 20. Current carrier of an orthopaedic prosthesis 21. Illiteracy 22. Alcohol (total daily alcohol daily intake >50 g) or drug abuse within the past six months 23. Any other condition that may contraindicate exercise or interfere with the completion of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of body weight using a calibrated scale.Measured at baseline, 12 weeks, 24 weeks and 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in fat mass using dual-energy x-rays absorptiometry 2. Changes in quality of life, using SF-36 questionnaire 3. Fasting blood glucose from blood analysis 4. Blood pressure, with a sphygmomanometer 5. Serum lipid profile from blood analysis 6. Resting plasma leptin concentration using ELISA 7. Maximal fat oxidation capacity. Exercise test with indirect calorimetry and (in patients agreeing to, mitochondrial respirometry in needle muscle biopsies obtained from the muscle vastus lateralis at the start of the study and at 24 weeks. All outcome measures will be assessed at baseline and 24 weeks. At 12 weeks, body fat, quality of life, fasting glucose, blood pressure and lipid profile will be assessed. At two years all outcome measures will be measured except maximal fat oxidation capacity. | — |
Countries
Spain
Contacts
Public ContactDavid Morales-Alamo
Outcome results
None listed