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Cardiometabolic DiseasesEMPOWER-BATNCT07837752

Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women

A study testing Aerobic exercise and Prolonged fasting in people with Cardiometabolic Diseases and Postmenopause, run by Universidad de Almeria at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate mitochondrial function in interscapular brown adipose tissue (iBAT) in postmenopausal women and determine whether aerobic exercise, prolonged fasting, or their combination can improve iBAT mitochondrial function and whole-body… Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cardiometabolic Diseases, Postmenopause
What is being tested?
Aerobic exercise and Prolonged fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
1 Sep 2027to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women aged 45 to 65 years.
  • Postmenopausal status, defined as ≥ 12 consecutive months without menstruation.
  • Women with amenorrhea shorter than 12 months will be included if their follicle-stimulating hormone levels are >30IU/liter.
  • BMI between ≥25 kg/m2.
  • Sedentary or low-active (not meeting physical activity guidelines).
  • Willing to be randomized to any of the four groups.
  • Able and willing to adhere to all study procedures and show availabity in their schedule.
  • Must be willing to have biological samples stored for future research.

Who cannot join

  • Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria).
  • Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia).
  • Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure).
  • Use of medication known to influence glucose and/or lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids).
  • Current or recent (past 6 months) use of hormone replacement therapy, including systemic estrogen therapy (oral or transdermal), combined estrogen-progestin therapy, tibolone, or selective estrogen receptor modulators.
  • Clinically relevant abnormalities in clinical chemistry or electrocardiogram at screening (to be judged by the study physician).
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  • A first-degree family member with sudden cardiac death.
  • Any chronic renal or hepatic disease.
  • Abuse of alcohol or other substances.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Borja Martínez Téllez, PhD contact

+34 950215334

borjammt@ual.es

Spain1 site
  • Universidad de Almería

    Almería, Almería, 04131

Other trials in Spain

About this study

Official title: Exercise and Prolonged Fasting to Improve Interscapular Brown Fat Mitochondrial Function and Enhance Metabolic Flexibility in Postmenopausal Women (EMPOWER-BAT)

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to investigate mitochondrial function in interscapular brown adipose tissue (iBAT) in postmenopausal women and determine whether aerobic exercise, prolonged fasting, or their combination can improve iBAT mitochondrial function and whole-body metabolic flexibility.

Read more

Participant Population/Health Conditions: The study will involve 60 postmenopausal women aged 45-65 years living with overweight or obesity.

Main Questions: The main questions this study aims to answer are:

  • What are the mitochondrial function and cellular characteristics of iBAT in postmenopausal women?
  • Can aerobic exercise or five-day prolonged fasting improve mitochondrial function in iBAT and whole-body metabolic flexibility?
  • Does combining aerobic exercise with prolonged fasting produce greater metabolic adaptations than either intervention alone?
  • Are improvements in metabolic flexibility maintained four weeks after the intervention?

Participants Will:

Be randomized into one of four groups: control, aerobic exercise, prolonged fasting, or combined aerobic exercise plus prolonged fasting.

Follow their assigned intervention for five consecutive days. Undergo metabolic and physiological assessments before and after the intervention and again four weeks later.

Provide dorsocervical adipose tissue biopsies and biological samples to investigate mitochondrial function, adipocyte characteristics, and metabolic adaptations.

Comparison Group: Researchers will compare the effects of aerobic exercise, prolonged fasting, and their combination with a control condition to determine their effects on iBAT mitochondrial function and whole-body metabolic flexibility.

Read the detailed description

Postmenopause is associated with a substantial increase in cardiometabolic risk, partly driven by the decline in estrogen levels and alterations in cellular energy metabolism. Mitochondrial dysfunction has been documented in skeletal muscle of postmenopausal women and is associated with metabolic inflexibility, reduced fat oxidation, ectopic fat accumulation, and insulin resistance. However, whether mitochondrial dysfunction is also present in adipose tissue of postmenopausal women, and whether it can be reversed through lifestyle interventions, remains largely unknown.

Brown adipose tissue (BAT) is a mitochondria-rich and metabolically active tissue involved in thermogenesis and substrate utilization. Although human BAT has traditionally been studied in the supraclavicular region, emerging evidence from our research group suggests the presence of a metabolically active adipose tissue depot in the dorsocervical region, referred to as interscapular brown adipose tissue (iBAT). Preliminary observations indicate that this depot may have distinct metabolic characteristics. However, iBAT has not yet been characterized in postmenopausal women.

Aerobic exercise is a potent non-pharmacological stimulus for mitochondrial remodeling and improves mitochondrial biogenesis and oxidative capacity. Exercise-derived lactate may also promote adipose tissue browning and mitochondrial remodeling. Prolonged fasting induces profound metabolic adaptations characterized by increased fat mobilization and changes in substrate utilization. Preliminary data from our group suggest that five days of prolonged fasting substantially increase fat oxidation during exercise, providing a rationale for investigating whether fasting and exercise may have complementary effects on mitochondrial function and metabolic flexibility.

Based on this rationale, the main hypothesis of EMPOWER-BAT is that iBAT in postmenopausal women presents mitochondrial dysfunction and that aerobic exercise, five-day prolonged fasting, and their combination can improve mitochondrial function through lactate-related signaling pathways, leading to enhanced whole-body metabolic flexibility. The main objective is to characterize mitochondrial function in iBAT and determine the effects of these interventions on iBAT mitochondrial function and metabolic flexibility.

EMPOWER-BAT is a randomized controlled trial involving 60 postmenopausal women aged 45-65 years with a body mass index ≥25 kg/m². Participants will be randomized (1:1:1:1) into four groups: a control group maintaining its usual lifestyle; an aerobic exercise group performing supervised exercise for 60-90 minutes at 65% of heart rate reserve; a prolonged fasting group following a medically supervised fasting protocol providing approximately 600 kcal/day; or a combined group completing both exercise and fasting. All interventions will last five consecutive days.

Before and after the intervention, iBAT biopsies will be collected from the dorsocervical region to assess mitochondrial function and adipocyte characteristics. Metabolic and physiological assessments will include indirect calorimetry at rest and during exercise, body composition, cardiorespiratory fitness, and blood and urine biomarkers. Continuous glucose and ketone monitoring will also be performed during the intervention. Four weeks later, metabolic and physiological assessments will be repeated to determine whether changes in metabolic flexibility are maintained after participants return to their usual lifestyle.

Being tested
Aerobic exercise, Prolonged fasting
Keywords
Brown adipose tissue, thermogenesis, women, postmenopause, exercise, fasting, metabolic flexibility
Medical subject headings
Motor Activity, Fasting

What participants receive

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

  • Aerobic exerciseBehavioural

    Participants will perform supervised aerobic exercise for 60-90 minutes per day at 65% of heart rate reserve on 5 consecutive days.

  • Prolonged fastingBehavioural

    Participants will follow a medically supervised prolonged fasting protocol providing approximately 600 kcal/day for five consecutive days.

Study groups in NCT07837752
Study groupRoleWhat they receive
ControlNo interventionn=15; maintaining their usual lifestyle without changes to diet or physical activity; Total 5 days
Aerobic exerciseExperimentaln=15; receiving supervised aerobic exercise for 60-90 minutes/day at 65% of heart rate reserve; Total 5 days
Receives: Behavioral: Aerobic exercise
Prolonged fastingExperimentaln=15; following a prolonged fasting protocol providing approximately 600 kcal/day; Total 5 days
Receives: Behavioral: Prolonged fasting
Aerobic exercise + prolonged fastingExperimentaln=15; receiving supervised aerobic exercise for 60-90 minutes/day at 65% of heart rate reserve and prolonged fasting providing approximately 600 kcal/day; Total 5 days
Receives: Behavioral: Aerobic exercise; Behavioral: Prolonged fasting

What is being measured

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

  1. iBAT adipocyte composition and gene expression (snRNA-seq)

    Change in adipocyte subpopulations and gene expression in dorsocervical iBAT assessed by single-nucleus RNA sequencing (snRNA-seq)

    Measured: 1 week

Secondary outcomes (21)
  1. iBAT mitochondrial respiration (Oroboros O2k).

    Change in mitochondrial respiration in dorsocervical iBAT assessed by high-resolution respirometry.

    Measured: 1 week

  2. iBAT protein expression (Western blot)

    Change in protein expression in dorsocervical iBAT assessed by Western blot, including markers related to thermogenesis and mitochondrial function.

    Measured: 1 week

  3. Total Body Fat Mass

    Change in total body fat mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).

    Measured: 5 weeks

  4. Body Fat Percentage

    Change in total body fat percentage (%) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).

    Measured: 5 weeks

  5. Resting Metabolic Rate

    Change in resting metabolic rate (kcal/day) from baseline, assessed by indirect calorimetry.

    Measured: 5 weeks

  6. Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)

    Change from baseline in peak oxygen uptake (VO₂peak; mL/kg/min), assessed during exercise testing with breath-by-breath gas exchange analysis.

    Measured: 5 weeks

  7. LDL Cholesterol

    Change in fasting LDL cholesterol (mg/dL) from baseline, assessed in blood samples.

    Measured: 5 weeks

  8. Urinary Urea Nitrogen

    Change from baseline in urinary urea nitrogen (UUN) concentration (mg/dL), assessed in urine samples as a marker of protein metabolism.

    Measured: 5 weeks

  9. Gut microbiota

    Change in gut microbiota composition assessed in fecal samples.

    Measured: 5 weeks

  10. Fat-Free Mass

    Change in total fat-free mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).

    Measured: 5 weeks

  11. Visceral Adipose Tissue (VAT) Fat Mass

    Change in visceral adipose tissue (VAT) fat mass (g) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).

    Measured: 5 weeks

  12. Subcutaneous Adipose Tissue (SAT) Fat Mass

    Change in subcutaneous adipose tissue (SAT) fat mass (g) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).

    Measured: 5 weeks

  13. Fat Oxidation Rate at Rest

    Change in resting fat oxidation rate (g/min) from baseline, calculated from oxygen consumption (VO₂) and carbon dioxide production (VCO₂) measured by indirect calorimetry.

    Measured: 5 weeks

  14. Carbohydrate Oxidation Rate at Rest

    Change in resting carbohydrate oxidation rate (g/min) from baseline, calculated from oxygen consumption (VO₂) and carbon dioxide production (VCO₂) measured by indirect calorimetry.

    Measured: 5 weeks

  15. HDL Cholesterol

    Change in fasting HDL cholesterol (mg/dL) from baseline, assessed in blood samples.

    Measured: 5 weeks

  16. Fasting Glucose

    Change in fasting blood glucose (mg/dL) from baseline.

    Measured: 5 weeks

  17. Fasting Insulin

    Change in fasting insulin concentration (µIU/mL) from baseline, assessed in blood samples.

    Measured: 5 weeks

  18. Triglycerides

    Change in fasting triglyceride concentration (mg/dL) from baseline, assessed in blood samples.

    Measured: 5 weeks

  19. C-Reactive Protein (CRP)

    Change in C-reactive protein concentration (mg/L) from baseline, assessed in blood samples.

    Measured: 5 weeks

  20. Fat Oxidation During Exercise

    Change from baseline in fat oxidation rate (g/min) during exercise, estimated by indirect calorimetry using a COSMED Quark metabolic cart.

    Measured: 5 weeks

  21. Carbohydrate Oxidation During Exercise

    Change from baseline in carbohydrate oxidation rate (g/min) during exercise, estimated by indirect calorimetry using a COSMED Quark metabolic cart.

    Measured: 5 weeks

Timeline

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

  1. First posted23 Sep 2026
  2. Study start1 Sep 2027 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

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
Model description
This study will consist of a randomized controlled trial in which 60 postmenopausal women with a BMI ≥27 kg/m² will be randomly assigned (1:1:1:1) to a control group (n=15; maintaining their usual lifestyle), an aerobic exercise group (n=15; supervised exercise for 60-90 minutes/day at 65% heart rate reserve), a prolonged fasting group (n=15; approximately 600 kcal/day), or a combined exercise plus fasting group (n=15; completing both interventions). All interventions will last five consecutive days.
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07837752
Sponsor's protocol ID
PID2025-173649OB-I00
Acronym
EMPOWER-BAT
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic exercise and Prolonged fasting in people with Cardiometabolic Diseases and Postmenopause, run by Universidad de Almeria 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Borja Martínez Téllez, PhD (+34 950215334, borjammt@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iBAT adipocyte composition and gene expression (snRNA-seq) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Sep 2026.

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