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Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women (EMPOWER-BAT)

17. září 2026 aktualizováno: Borja Martínez Tellez, Universidad de Almeria

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.

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Borja Martínez Téllez, PhD
  • Telefonní číslo: +34 950215334
  • E-mail: borjammt@ual.es

Studijní místa

    • Almería
      • Almería, Almería, Španělsko, 04131
        • Universidad de Almería

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

45 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • A first-degree family member with sudden cardiac death.
  • Any chronic renal or hepatic disease.
  • Abuse of alcohol or other substances.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Control

n=15; maintaining their usual lifestyle without changes to diet or physical activity; Total 5 days

Experimentální: Aerobic exercise

n=15; receiving supervised aerobic exercise for 60-90 minutes/day at 65% of heart rate reserve; Total 5 days

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

Experimentální: Prolonged fasting

n=15; following a prolonged fasting protocol providing approximately 600 kcal/day; Total 5 days

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

Experimentální: Aerobic exercise + 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

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
iBAT adipocyte composition and gene expression (snRNA-seq)
Časové okno: 1 week

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

1 week

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
iBAT mitochondrial respiration (Oroboros O2k).
Časové okno: 1 week

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

1 week
iBAT protein expression (Western blot)
Časové okno: 1 week

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

1 week
Total Body Fat Mass
Časové okno: 5 weeks

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

5 weeks
Body Fat Percentage
Časové okno: 5 weeks

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

5 weeks
Resting Metabolic Rate
Časové okno: 5 weeks

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

5 weeks
Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)
Časové okno: 5 weeks

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

5 weeks
LDL Cholesterol
Časové okno: 5 weeks

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

5 weeks
Urinary Urea Nitrogen
Časové okno: 5 weeks

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

5 weeks
Gut microbiota
Časové okno: 5 weeks

Change in gut microbiota composition assessed in fecal samples.

5 weeks
Fat-Free Mass
Časové okno: 5 weeks

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

5 weeks
Visceral Adipose Tissue (VAT) Fat Mass
Časové okno: 5 weeks

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

5 weeks
Subcutaneous Adipose Tissue (SAT) Fat Mass
Časové okno: 5 weeks

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

5 weeks
Fat Oxidation Rate at Rest
Časové okno: 5 weeks

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

5 weeks
Carbohydrate Oxidation Rate at Rest
Časové okno: 5 weeks

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

5 weeks
HDL Cholesterol
Časové okno: 5 weeks

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

5 weeks
Fasting Glucose
Časové okno: 5 weeks

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

5 weeks
Fasting Insulin
Časové okno: 5 weeks

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

5 weeks
Triglycerides
Časové okno: 5 weeks

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

5 weeks
C-Reactive Protein (CRP)
Časové okno: 5 weeks

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

5 weeks
Fat Oxidation During Exercise
Časové okno: 5 weeks

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

5 weeks
Carbohydrate Oxidation During Exercise
Časové okno: 5 weeks

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

5 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2027

Primární dokončení (Odhadovaný)

1. září 2029

Dokončení studie (Odhadovaný)

1. září 2029

Termíny zápisu do studia

První předloženo

9. září 2026

První předloženo, které splnilo kritéria kontroly kvality

17. září 2026

První zveřejněno (Aktuální)

23. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Časový rámec sdílení IPD

5 years after publishing the data

Kritéria přístupu pro sdílení IPD

Everybody

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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