ObesityACTIBATENCT02365129
Activating Brown Adipose Tissue Through Exercise
A study testing Exercise training based on recommendations for adults (WHO) in people with Obesity and Diabetes Mellitus, run by Universidad de Granada at 1 site in Spain.
Trial summary
The energy burning capacity of brown adipose tissue makes it an attractive target for anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators that sidestep the need for stimulating the… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Metabolic Syndrome X
- What is being tested?
- Exercise training based on recommendations for adults (WHO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Jul 2017
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 20-35 kg/m2.
- Not engaged in regular physical activity >20 min on >3 days/week.
- Not participating in a weight loss program.
- Stable weight over the last 3 months (body weight changes <3 kg).
- Normal electrocardiogram.
- Participants must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment.
Who cannot join
- History of cardiovascular disease.
- Diabetes or hypertension.
- Pregnancy, or planning to get pregnant during the study period.
- Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
- Beta blockers or benzodiazepins use.
- Smoking.
Show all 10Show fewer
- Frequent exposure to cold temperatures (Granada is surrounded by high mountains where people can sky or do trekking).
- Taking medication for thyroid.
- Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
- Unwillingness to either complete the study requirements or to be randomized into control or training group.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, Granada, 18011
Jonatan R Ruiz, PhD, 0034958242754, ruizj@ugr.es
Jonatan Ruiz, PhD
About this study
Official title: Activating Brown Adipose Tissue Through Exercise: Randomized Controlled Trial
The energy burning capacity of brown adipose tissue makes it an attractive target for anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators that sidestep the need for stimulating the SNS, including cardiac natriuretic peptides. Of interest is that both SNS and non-SNS brown adipose tissue activators are sensitive to physical exercise, which opens new horizons and opportunities to study the potential effect of exercise-based therapeutic interventions. Moreover, a new protein released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program of white adipose tissue. Most of the available evidence comes from animal studies, which is sometimes difficult to infer to human physiology. The overall objective of the ACTIBATE randomized controlled trial is to study the effect of long-term exercise training (6 months) on brown adipose tissue activity and quantity (primary outcomes) in young overweight and obese adults. The clinical significance of activating and recruiting brown adipose tissue on resting metabolic rate and cardiometabolic profile in humans will be determined. The investigators will also study at the molecular level the benefits of exercise on the regulation pathways in two different tissues: white adipose tissue and skeletal muscle, as well as identifying possible cross-talk between the exercising muscle and heart, and fat. Information from exercise-induced signaling on brown adipose tissue, white adipose tissue and skeletal muscle will help on identifying potential molecular therapeutic candidates.
Read the detailed description
The energy burning capacity of brown adipose tissue (BAT) makes it an attractive target for antiobesity therapies. Sympathetic nervous system (SNS) is the classical regulator of BAT; however, recent findings show a pool of novel BAT activators that sidestep the need for stimulating the SNS. Of interest is that both SNS and non-SNS BAT activators are sensitive to physical exercise, which opens new horizons and opportunities to study the potential effect of exercise-based therapeutic interventions. Moreover, a new protein released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program in white adipose tissue. Most of the available evidence comes from animal studies, which is sometimes difficult to infer to human physiology. To determine whether a controlled physical exercise program is able to facilitate BAT maintenance and function, stimulating pre-existing brown precursors and inducing the specific gene program to favor white-to-brown adipocyte transformation in humans is of clinical relevance.
The primary objective of the ACTIBATE randomized controlled trial (RCT) is to quantify the dose-effect of different exercise intensities, i.e. no exercise, moderate-intensity and vigorous-intensity, on BAT activity and mass (primary outcome), and on energy expenditure, thermogenic response to a test meal, shivering threshold, and cardiovascular disease risk factors, in young adults. The investigators will also obtain biopsies from white adipose tissue and skeletal muscle to analyse the expression of genes encoding proteins involved in the thermogenic machinery. The intervention groups will train 4-5 days/week (60 min per session) for a 24-week period.
With the final aim of making the exercise program transferable to society, the basis for the specific exercise dose in ACTIBATE is the physical activity recommendations for adults proposed by the World Health Organization. Since there is no information regarding the ideal exercise model to activate and recruit BAT, a major objective of ACTIBATE is to evaluate various exercise intensity levels that fall within the current public health recommendations to test whether higher intensity levels provides more benefit than the standard moderate-intensity level. ACTIBATE will combine both aerobic and resistance training.
- Conditions
- Obesity, Diabetes Mellitus, Metabolic Syndrome X
- Being tested
- Exercise training based on recommendations for adults (WHO)
- Keywords
- BRITE adipose tissue, physical activity, Thermogenesis, Body Temperature Regulation, Energy Metabolism
- Medical subject headings
- Obesity, Diabetes Mellitus, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training based on recommendations for adults (WHO)Other
The length of the trial will be 6 months. the total time of aerobic exercise in both moderate-intensity and vigorous-intensity groups will be 150 minutes/week, whereas the time needed to complete the resistance training exercises will be ≈15-30 minutes for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group (control) | No intervention | Participants randomly assigned to the usual care (control) group will receive general advices from the exercise-training specialist about the positive effects of physical activity at the start of the study. The investigators will prepare informative pamphlets describing the benefits of physical activity that the investigators group has prepared for the Region of Andalucía (Southern Spain),http://www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf. |
| Moderate-intensity group | Experimental | Exercise training based on recommendations for adults (WHO) Receives: Other: Exercise training based on recommendations for adults (WHO) |
| Vigorous-intensity group | Experimental | Exercise training based on recommendations for adults (WHO) Receives: Other: Exercise training based on recommendations for adults (WHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in BAT mass and activity evaluated with Positron emission tomography/computed tomography (PET/CT)
Measured: Baseline and 6 month later (immediately after the interventions ends)
Secondary outcomes (21)
Change from Baseline in gene expression of white adipose tissue, aliquots will be obtained by biopsies.
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in gene expression of muscle, aliquots will be obtained by biopsies.
Aliquots will be designated to gene expression, immunoblotting and morphologic studies.
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in resting energy expenditure measured through indirect calorimetry
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in meal Induced Thermogenesis measured through indirect calorimetry
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Cold Induced Thermogenesis measured through indirect calorimetry
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Body composition: fat mass. Using a Dual Energy X-ray Absorptiometry scan
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Body composition: lean body mass Using a Dual Energy X-ray Absorptiometry scan
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Shivering threshold: Temperature of water in a water perfuse vest connected to a chiller unit
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to cold exposure with both subjective (Visual Analog Scales) and objective measures (skin and sublingual temperature)
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in subjective Thermic response to cold exposure: Visual Analog Scale
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to a test meal with skin temperature
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Appetite: ad-libitum meal
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Appetite: Visual Analog Scale after a test meal
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Lipid Profile: In a blood sample
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in biomolecular markers: energy metabolism during cold exposure: In a blood sample
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to a maximum effort test record with skin thermal receptors
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Muscular strength: 1 Repetition Maximum
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Dietary habits: 24h questionaire
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Physical activity levels: With an accelerometer
Measured: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Basal Heart Rate Variability: with a heart rate monitor
Measured: Baseline and 6 month later (immediately after the interventions ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
- Investigators
- Jonatan R Ruiz, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365129
- Sponsor's protocol ID
- PI13/01393
- Acronym
- ACTIBATE
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez-Tellez B, Schonke M, Kovynev A, Garcia-Dominguez E, Ortiz-Alvarez L, Verhoeven A, Gacesa R, Vich Vila A, Ducarmon QR, Jimenez-Pavon D, Gomez-Cabrera MDC, Weersma RK, Smits WK, Giera M, Ruiz JR, Rensen PC. Roseburia inulinivorans increases muscle strength. Gut. 2026 Mar 10:gutjnl-2025-336980. doi: 10.1136/gutjnl-2025-336980. Online ahead of print.
PubMed 41806991Martin-Olmedo JJ, Jurado-Fasoli L, Osuna-Prieto FJ, Garcia-Fontana C, Garcia-Fontana B, Gracia-Marco L, Munoz-Torres M, Ruiz JR. Impact of 24-week concurrent training on bone parameters and plasma levels of osteoglycin and sclerostin in young, sedentary adults: secondary analyses from the ACTIBATE randomized controlled trial. Eur J Endocrinol. 2025 Apr 30;192(5):558-567. doi: 10.1093/ejendo/lvaf087.
PubMed 40298018Martinez-Tellez B, Xu H, Ortiz-Alvarez L, Rodriguez-Garcia C, Schonke M, Jurado-Fasoli L, Osuna-Prieto FJ, Alcantara JMA, Acosta FM, Amaro-Gahete FJ, Folkerts G, Vilchez-Vargas R, Link A, Plaza-Diaz J, Gil A, Labayen I, Fernandez-Veledo S, Rensen PCN, Ruiz JR. Effect of a 24-week supervised concurrent exercise intervention on fecal microbiota diversity and composition in young sedentary adults: The ACTIBATE randomized controlled trial. Clin Nutr. 2025 Jun;49:128-137. doi: 10.1016/j.clnu.2025.04.008. Epub 2025 Apr 15.
PubMed 40279809Amaro-Gahete FJ, Espuch-Oliver A, Cano-Nieto A, Alcantara JMA, Garcia-Lario JV, De Haro T, Llamas-Elvira JM, Munoz Torres M, Castillo MJ, Labayen I, Ruiz JR. Impact of 24-week supervised concurrent exercise on S-Klotho and vitamin D levels: A randomized controlled trial. J Sports Sci. 2024 Dec;42(24):2562-2571. doi: 10.1080/02640414.2025.2453328. Epub 2025 Jan 20.
PubMed 39831661Alcantara JMA, Gonzalez-Acedo A, Amaro-Gahete FJ, Plaza-Florido A. Heart Rate and Its Variability Are Associated With Resting Metabolic Rate and Substrate Oxidation in Young Women but Not in Men. Am J Hum Biol. 2024 Nov;36(11):e24157. doi: 10.1002/ajhb.24157. Epub 2024 Sep 20.
PubMed 39300911Dote-Montero M, Acosta FM, Sanchez-Delgado G, Merchan-Ramirez E, Amaro-Gahete FJ, Labayen I, Ruiz JR. Association of meal timing with body composition and cardiometabolic risk factors in young adults. Eur J Nutr. 2023 Aug;62(5):2303-2315. doi: 10.1007/s00394-023-03141-9. Epub 2023 Apr 26.
PubMed 37100891Jurado-Fasoli L, Di X, Sanchez-Delgado G, Yang W, Osuna-Prieto FJ, Ortiz-Alvarez L, Krekels E, Harms AC, Hankemeier T, Schonke M, Aguilera CM, Llamas-Elvira JM, Kohler I, Rensen PCN, Ruiz JR, Martinez-Tellez B. Acute and long-term exercise differently modulate plasma levels of oxylipins, endocannabinoids, and their analogues in young sedentary adults: A sub-study and secondary analyses from the ACTIBATE randomized controlled-trial. EBioMedicine. 2022 Nov;85:104313. doi: 10.1016/j.ebiom.2022.104313. Epub 2022 Oct 27.
PubMed 36374769Ortiz-Alvarez L, Acosta FM, Xu H, Sanchez-Delgado G, Vilchez-Vargas R, Link A, Plaza-Diaz J, Llamas JM, Gil A, Labayen I, Rensen PCN, Ruiz JR, Martinez-Tellez B. Fecal microbiota composition is related to brown adipose tissue 18F-fluorodeoxyglucose uptake in young adults. J Endocrinol Invest. 2023 Mar;46(3):567-576. doi: 10.1007/s40618-022-01936-x. Epub 2022 Oct 15.
PubMed 36242744Martinez-Tellez B, Sanchez-Delgado G, Acosta FM, Alcantara JMA, Amaro-Gahete FJ, Martinez-Avila WD, Merchan-Ramirez E, Munoz-Hernandez V, Osuna-Prieto FJ, Jurado-Fasoli L, Xu H, Ortiz-Alvarez L, Arias-Tellez MJ, Mendez-Gutierrez A, Labayen I, Ortega FB, Schonke M, Rensen PCN, Aguilera CM, Llamas-Elvira JM, Gil A, Ruiz JR. No evidence of brown adipose tissue activation after 24 weeks of supervised exercise training in young sedentary adults in the ACTIBATE randomized controlled trial. Nat Commun. 2022 Sep 12;13(1):5259. doi: 10.1038/s41467-022-32502-x.
PubMed 36097264Merchan-Ramirez E, Sanchez-Delgado G, Arrizabalaga-Arriazu C, Acosta FM, Arias-Tellez MJ, Munoz-Torres M, Garcia-Lario JV, Llamas-Elvira JM, Ruiz JR. Circulating concentrations of free triiodothyronine are associated with central adiposity and cardiometabolic risk factors in young euthyroid adults. J Physiol Biochem. 2022 Aug;78(3):629-640. doi: 10.1007/s13105-022-00881-w. Epub 2022 Apr 6.
PubMed 35381950Mendez-Gutierrez A, Aguilera CM, Osuna-Prieto FJ, Martinez-Tellez B, Rico Prados MC, Acosta FM, Llamas-Elvira JM, Ruiz JR, Sanchez-Delgado G. Exercise-induced changes on exerkines that might influence brown adipose tissue metabolism in young sedentary adults. Eur J Sport Sci. 2023 Apr;23(4):625-636. doi: 10.1080/17461391.2022.2040597. Epub 2022 Apr 25.
PubMed 35152857Acosta FM, Sanchez-Delgado G, Martinez-Tellez B, Alcantara JMA, Llamas-Elvira JM, Ruiz JR. Diurnal variations of cold-induced thermogenesis in young, healthy adults: A randomized crossover trial. Clin Nutr. 2021 Oct;40(10):5311-5321. doi: 10.1016/j.clnu.2021.08.010. Epub 2021 Aug 24.
PubMed 34536639Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1.
PubMed 33549436Sanchez-Delgado G, Alcantara JMA, Acosta FM, Martinez-Tellez B, Amaro-Gahete FJ, Merchan-Ramirez E, Lof M, Labayen I, Ravussin E, Ruiz JR. Energy Expenditure and Macronutrient Oxidation in Response to an Individualized Nonshivering Cooling Protocol. Obesity (Silver Spring). 2020 Nov;28(11):2175-2183. doi: 10.1002/oby.22972. Epub 2020 Sep 27.
PubMed 32985119Sanchez-Delgado G, Acosta FM, Martinez-Tellez B, Finlayson G, Gibbons C, Labayen I, Llamas-Elvira JM, Gil A, Blundell JE, Ruiz JR. Brown adipose tissue volume and 18F-fluorodeoxyglucose uptake are not associated with energy intake in young human adults. Am J Clin Nutr. 2020 Feb 1;111(2):329-339. doi: 10.1093/ajcn/nqz300.
PubMed 31826235
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Brown Adipose Tissue Through Exercise: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02365129
- Acronym / sponsor ID
- ACTIBATE / PI13/01393
- Conditions
- Obesity, Diabetes Mellitus, Metabolic Syndrome X
- Keywords
- BRITE adipose tissue, physical activity, Thermogenesis, Body Temperature Regulation, Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Study start
- Feb 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The energy burning capacity of brown adipose tissue makes it an attractive target for anti-obesity therapies. Sympathetic nervous system (SNS) is the classical regulator of brown adipose tissue; however, recent findings show a pool of novel brown adipose tissue activators that sidestep the need for stimulating the SNS, including cardiac natriuretic peptides. Of interest is that both SNS and non-SNS brown adipose tissue activators are sensitive to physical exercise, which opens new horizons and opportunities to study the potential effect of exercise-based therapeutic interventions. Moreover, a new protein released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program of white adipose tissue. Most of the available evidence comes from animal studies, which is sometimes difficult to infer to human physiology. The overall objective of the ACTIBATE randomized controlled trial is to study the effect of long-term exercise training (6 months) on brown adipose tissue activity and quantity (primary outcomes) in young overweight and obese adults. The clinical significance of activating and recruiting brown adipose tissue on resting metabolic rate and cardiometabolic profile in humans will be determined. The investigators will also study at the molecular level the benefits of exercise on the regulation pathways in two different tissues: white adipose tissue and skeletal muscle, as well as identifying possible cross-talk between the exercising muscle and heart, and fat. Information from exercise-induced signaling on brown adipose tissue, white adipose tissue and skeletal muscle will help on identifying potential molecular therapeutic candidates.
Detailed description
The energy burning capacity of brown adipose tissue (BAT) makes it an attractive target for antiobesity therapies. Sympathetic nervous system (SNS) is the classical regulator of BAT; however, recent findings show a pool of novel BAT activators that sidestep the need for stimulating the SNS. Of interest is that both SNS and non-SNS BAT activators are sensitive to physical exercise, which opens new horizons and opportunities to study the potential effect of exercise-based therapeutic interventions. Moreover, a new protein released by exercise-stimulated skeletal muscle, irisin, seems to play a key role in the browning program in white adipose tissue. Most of the available evidence comes from animal studies, which is sometimes difficult to infer to human physiology. To determine whether a controlled physical exercise program is able to facilitate BAT maintenance and function, stimulating pre-existing brown precursors and inducing the specific gene program to favor white-to-brown adipocyte transformation in humans is of clinical relevance.
The primary objective of the ACTIBATE randomized controlled trial (RCT) is to quantify the dose-effect of different exercise intensities, i.e. no exercise, moderate-intensity and vigorous-intensity, on BAT activity and mass (primary outcome), and on energy expenditure, thermogenic response to a test meal, shivering threshold, and cardiovascular disease risk factors, in young adults. The investigators will also obtain biopsies from white adipose tissue and skeletal muscle to analyse the expression of genes encoding proteins involved in the thermogenic machinery. The intervention groups will train 4-5 days/week (60 min per session) for a 24-week period.
With the final aim of making the exercise program transferable to society, the basis for the specific exercise dose in ACTIBATE is the physical activity recommendations for adults proposed by the World Health Organization. Since there is no information regarding the ideal exercise model to activate and recruit BAT, a major objective of ACTIBATE is to evaluate various exercise intensity levels that fall within the current public health recommendations to test whether higher intensity levels provides more benefit than the standard moderate-intensity level. ACTIBATE will combine both aerobic and resistance training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care group (control) | No intervention | –Participants randomly assigned to the usual care (control) group will receive general advices from the exercise-training specialist about the positive effects of physical activity at the start of the study. The investigators will prepare informative pamphlets describing the benefits of physical activity that the investigators group has prepared for the Region of Andalucía (Southern Spain),http://www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf. |
| Moderate-intensity group | Experimental | Other: Exercise training based on recommendations for adults (WHO)Exercise training based on recommendations for adults (WHO) |
| Vigorous-intensity group | Experimental | Other: Exercise training based on recommendations for adults (WHO)Exercise training based on recommendations for adults (WHO) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI: 20-35 kg/m2.
- Not engaged in regular physical activity >20 min on >3 days/week.
- Not participating in a weight loss program.
- Stable weight over the last 3 months (body weight changes <3 kg).
- Normal electrocardiogram.
Key exclusion criteria (10 listed)
- History of cardiovascular disease.
- Diabetes or hypertension.
- Pregnancy, or planning to get pregnant during the study period.
- Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
- Beta blockers or benzodiazepins use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training based on recommendations for adults (WHO)The length of the trial will be 6 months. the total time of aerobic exercise in both moderate-intensity and vigorous-intensity groups will be 150 minutes/week, whereas the time needed to complete the resistance training exercises will be ≈15-30 minutes for both groups. | Other | Moderate-intensity group, Vigorous-intensity group |
Primary outcome
Change from Baseline in BAT mass and activity evaluated with Positron emission tomography/computed tomography (PET/CT)
Time frame: Baseline and 6 month later (immediately after the interventions ends)
21 secondary outcomes
Change from Baseline in gene expression of white adipose tissue, aliquots will be obtained by biopsies.
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in gene expression of muscle, aliquots will be obtained by biopsies.
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in resting energy expenditure measured through indirect calorimetry
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in meal Induced Thermogenesis measured through indirect calorimetry
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Cold Induced Thermogenesis measured through indirect calorimetry
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Body composition: fat mass. Using a Dual Energy X-ray Absorptiometry scan
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Body composition: lean body mass Using a Dual Energy X-ray Absorptiometry scan
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Shivering threshold: Temperature of water in a water perfuse vest connected to a chiller unit
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to cold exposure with both subjective (Visual Analog Scales) and objective measures (skin and sublingual temperature)
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in subjective Thermic response to cold exposure: Visual Analog Scale
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to a test meal with skin temperature
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Appetite: ad-libitum meal
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Appetite: Visual Analog Scale after a test meal
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Lipid Profile: In a blood sample
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in biomolecular markers: energy metabolism during cold exposure: In a blood sample
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Cardiorespiratory fitness measured on a maximum effort test
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Thermic response to a maximum effort test record with skin thermal receptors
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Muscular strength: 1 Repetition Maximum
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Dietary habits: 24h questionaire
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Physical activity levels: With an accelerometer
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Change from Baseline in Basal Heart Rate Variability: with a heart rate monitor
Time frame: Baseline and 6 month later (immediately after the interventions ends)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Derived from this study: PubMed 41806991Martinez-Tellez B, Schonke M, Kovynev A, Garcia-Dominguez E, Ortiz-Alvarez L, Verhoeven A, Gacesa R, Vich Vila A, Ducarmon QR, Jimenez-Pavon D, Gomez-Cabrera MDC, Weersma RK, Smits WK, Giera M, Ruiz JR, Rensen PC. Roseburia inulinivorans increases muscle strength. Gut. 2026 Mar 10:gutjnl-2025-336980. doi: 10.1136/gutjnl-2025-336980. Online ahead of print.
- Derived from this study: PubMed 40298018Martin-Olmedo JJ, Jurado-Fasoli L, Osuna-Prieto FJ, Garcia-Fontana C, Garcia-Fontana B, Gracia-Marco L, Munoz-Torres M, Ruiz JR. Impact of 24-week concurrent training on bone parameters and plasma levels of osteoglycin and sclerostin in young, sedentary adults: secondary analyses from the ACTIBATE randomized controlled trial. Eur J Endocrinol. 2025 Apr 30;192(5):558-567. doi: 10.1093/ejendo/lvaf087.
- Derived from this study: PubMed 40279809Martinez-Tellez B, Xu H, Ortiz-Alvarez L, Rodriguez-Garcia C, Schonke M, Jurado-Fasoli L, Osuna-Prieto FJ, Alcantara JMA, Acosta FM, Amaro-Gahete FJ, Folkerts G, Vilchez-Vargas R, Link A, Plaza-Diaz J, Gil A, Labayen I, Fernandez-Veledo S, Rensen PCN, Ruiz JR. Effect of a 24-week supervised concurrent exercise intervention on fecal microbiota diversity and composition in young sedentary adults: The ACTIBATE randomized controlled trial. Clin Nutr. 2025 Jun;49:128-137. doi: 10.1016/j.clnu.2025.04.008. Epub 2025 Apr 15.
- Derived from this study: PubMed 39831661Amaro-Gahete FJ, Espuch-Oliver A, Cano-Nieto A, Alcantara JMA, Garcia-Lario JV, De Haro T, Llamas-Elvira JM, Munoz Torres M, Castillo MJ, Labayen I, Ruiz JR. Impact of 24-week supervised concurrent exercise on S-Klotho and vitamin D levels: A randomized controlled trial. J Sports Sci. 2024 Dec;42(24):2562-2571. doi: 10.1080/02640414.2025.2453328. Epub 2025 Jan 20.
- Derived from this study: PubMed 39300911Alcantara JMA, Gonzalez-Acedo A, Amaro-Gahete FJ, Plaza-Florido A. Heart Rate and Its Variability Are Associated With Resting Metabolic Rate and Substrate Oxidation in Young Women but Not in Men. Am J Hum Biol. 2024 Nov;36(11):e24157. doi: 10.1002/ajhb.24157. Epub 2024 Sep 20.
- Derived from this study: PubMed 37100891Dote-Montero M, Acosta FM, Sanchez-Delgado G, Merchan-Ramirez E, Amaro-Gahete FJ, Labayen I, Ruiz JR. Association of meal timing with body composition and cardiometabolic risk factors in young adults. Eur J Nutr. 2023 Aug;62(5):2303-2315. doi: 10.1007/s00394-023-03141-9. Epub 2023 Apr 26.
- Derived from this study: PubMed 36374769Jurado-Fasoli L, Di X, Sanchez-Delgado G, Yang W, Osuna-Prieto FJ, Ortiz-Alvarez L, Krekels E, Harms AC, Hankemeier T, Schonke M, Aguilera CM, Llamas-Elvira JM, Kohler I, Rensen PCN, Ruiz JR, Martinez-Tellez B. Acute and long-term exercise differently modulate plasma levels of oxylipins, endocannabinoids, and their analogues in young sedentary adults: A sub-study and secondary analyses from the ACTIBATE randomized controlled-trial. EBioMedicine. 2022 Nov;85:104313. doi: 10.1016/j.ebiom.2022.104313. Epub 2022 Oct 27.
- Derived from this study: PubMed 36242744Ortiz-Alvarez L, Acosta FM, Xu H, Sanchez-Delgado G, Vilchez-Vargas R, Link A, Plaza-Diaz J, Llamas JM, Gil A, Labayen I, Rensen PCN, Ruiz JR, Martinez-Tellez B. Fecal microbiota composition is related to brown adipose tissue 18F-fluorodeoxyglucose uptake in young adults. J Endocrinol Invest. 2023 Mar;46(3):567-576. doi: 10.1007/s40618-022-01936-x. Epub 2022 Oct 15.
- Derived from this study: PubMed 36097264Martinez-Tellez B, Sanchez-Delgado G, Acosta FM, Alcantara JMA, Amaro-Gahete FJ, Martinez-Avila WD, Merchan-Ramirez E, Munoz-Hernandez V, Osuna-Prieto FJ, Jurado-Fasoli L, Xu H, Ortiz-Alvarez L, Arias-Tellez MJ, Mendez-Gutierrez A, Labayen I, Ortega FB, Schonke M, Rensen PCN, Aguilera CM, Llamas-Elvira JM, Gil A, Ruiz JR. No evidence of brown adipose tissue activation after 24 weeks of supervised exercise training in young sedentary adults in the ACTIBATE randomized controlled trial. Nat Commun. 2022 Sep 12;13(1):5259. doi: 10.1038/s41467-022-32502-x.
- Derived from this study: PubMed 35381950Merchan-Ramirez E, Sanchez-Delgado G, Arrizabalaga-Arriazu C, Acosta FM, Arias-Tellez MJ, Munoz-Torres M, Garcia-Lario JV, Llamas-Elvira JM, Ruiz JR. Circulating concentrations of free triiodothyronine are associated with central adiposity and cardiometabolic risk factors in young euthyroid adults. J Physiol Biochem. 2022 Aug;78(3):629-640. doi: 10.1007/s13105-022-00881-w. Epub 2022 Apr 6.
- Derived from this study: PubMed 35152857Mendez-Gutierrez A, Aguilera CM, Osuna-Prieto FJ, Martinez-Tellez B, Rico Prados MC, Acosta FM, Llamas-Elvira JM, Ruiz JR, Sanchez-Delgado G. Exercise-induced changes on exerkines that might influence brown adipose tissue metabolism in young sedentary adults. Eur J Sport Sci. 2023 Apr;23(4):625-636. doi: 10.1080/17461391.2022.2040597. Epub 2022 Apr 25.
- Derived from this study: PubMed 34536639Acosta FM, Sanchez-Delgado G, Martinez-Tellez B, Alcantara JMA, Llamas-Elvira JM, Ruiz JR. Diurnal variations of cold-induced thermogenesis in young, healthy adults: A randomized crossover trial. Clin Nutr. 2021 Oct;40(10):5311-5321. doi: 10.1016/j.clnu.2021.08.010. Epub 2021 Aug 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonatan R Ruiz, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training based on recommendations for adults (WHO) in people with Obesity and Diabetes Mellitus, run by Universidad de Granada 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Feb 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonatan R Ruiz, PhD (+34 958 242 754, ruizj@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in BAT mass and activity evaluated with Positron emission tomography/computed tomography (PET/CT) (time frame: Baseline and 6 month later (immediately after the interventions ends)). 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 NCT02365129, which also lists 19 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 18 Feb 2015.