An interventional study of Aerobic exercise and Prolonged fasting in Cardiometabolic Diseases and Postmenopause, sponsored by Universidad de Almeria. Not yet recruiting at 1 site in Spain. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Basic science
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.
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:
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.
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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 311 interventional studies indexed under Fasting.
Browse Fasting studies →Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
Compared within Fasting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
n=15; maintaining their usual lifestyle without changes to diet or physical activity; Total 5 days
n=15; receiving supervised aerobic exercise for 60-90 minutes/day at 65% of heart rate reserve; Total 5 days
Behavioral: Aerobic exercise
n=15; following a prolonged fasting protocol providing approximately 600 kcal/day; Total 5 days
Behavioral: Prolonged fasting
n=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
Behavioral: Aerobic exercise · Behavioral: Prolonged fasting
Participants will perform supervised aerobic exercise for 60-90 minutes per day at 65% of heart rate reserve on 5 consecutive days.
Participants will follow a medically supervised prolonged fasting protocol providing approximately 600 kcal/day for five consecutive days.
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)
Time frame: 1 week
iBAT mitochondrial respiration (Oroboros O2k).
Change in mitochondrial respiration in dorsocervical iBAT assessed by high-resolution respirometry.
Time frame: 1 week
iBAT protein expression (Western blot)
Change in protein expression in dorsocervical iBAT assessed by Western blot, including markers related to thermogenesis and mitochondrial function.
Time frame: 1 week
Total Body Fat Mass
Change in total body fat mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).
Time frame: 5 weeks
Body Fat Percentage
Change in total body fat percentage (%) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).
Time frame: 5 weeks
Resting Metabolic Rate
Change in resting metabolic rate (kcal/day) from baseline, assessed by indirect calorimetry.
Time frame: 5 weeks
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.
Time frame: 5 weeks
LDL Cholesterol
Change in fasting LDL cholesterol (mg/dL) from baseline, assessed in blood samples.
Time frame: 5 weeks
Urinary Urea Nitrogen
Change from baseline in urinary urea nitrogen (UUN) concentration (mg/dL), assessed in urine samples as a marker of protein metabolism.
Time frame: 5 weeks
Gut microbiota
Change in gut microbiota composition assessed in fecal samples.
Time frame: 5 weeks
Fat-Free Mass
Change in total fat-free mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).
Time frame: 5 weeks
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).
Time frame: 5 weeks
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).
Time frame: 5 weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks
HDL Cholesterol
Change in fasting HDL cholesterol (mg/dL) from baseline, assessed in blood samples.
Time frame: 5 weeks
Fasting Glucose
Change in fasting blood glucose (mg/dL) from baseline.
Time frame: 5 weeks
Fasting Insulin
Change in fasting insulin concentration (µIU/mL) from baseline, assessed in blood samples.
Time frame: 5 weeks
Triglycerides
Change in fasting triglyceride concentration (mg/dL) from baseline, assessed in blood samples.
Time frame: 5 weeks
C-Reactive Protein (CRP)
Change in C-reactive protein concentration (mg/L) from baseline, assessed in blood samples.
Time frame: 5 weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: 5 years after publishing the data
Access criteria: Everybody
Data sharing details ↗ · www.sportresearchgroup.es
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Universidad de Almeria