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

17 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Borja Martínez Téllez, PhD
  • Numer telefonu: +34 950215334
  • E-mail: borjammt@ual.es

Lokalizacje studiów

    • Almería
      • Almería, Almería, Hiszpania, 04131
        • Universidad de Almería

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control

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

Eksperymentalny: 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.

Eksperymentalny: 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.

Eksperymentalny: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
iBAT adipocyte composition and gene expression (snRNA-seq)
Ramy czasowe: 1 week

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

1 week

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
iBAT mitochondrial respiration (Oroboros O2k).
Ramy czasowe: 1 week

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

1 week
iBAT protein expression (Western blot)
Ramy czasowe: 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
Ramy czasowe: 5 weeks

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

5 weeks
Body Fat Percentage
Ramy czasowe: 5 weeks

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

5 weeks
Resting Metabolic Rate
Ramy czasowe: 5 weeks

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

5 weeks
Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)
Ramy czasowe: 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
Ramy czasowe: 5 weeks

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

5 weeks
Urinary Urea Nitrogen
Ramy czasowe: 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
Ramy czasowe: 5 weeks

Change in gut microbiota composition assessed in fecal samples.

5 weeks
Fat-Free Mass
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 5 weeks

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

5 weeks
Fasting Glucose
Ramy czasowe: 5 weeks

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

5 weeks
Fasting Insulin
Ramy czasowe: 5 weeks

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

5 weeks
Triglycerides
Ramy czasowe: 5 weeks

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

5 weeks
C-Reactive Protein (CRP)
Ramy czasowe: 5 weeks

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

5 weeks
Fat Oxidation During Exercise
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2027

Zakończenie podstawowe (Szacowany)

1 września 2029

Ukończenie studiów (Szacowany)

1 września 2029

Daty rejestracji na studia

Pierwszy przesłany

9 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 września 2026

Pierwszy wysłany (Rzeczywisty)

23 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • PID2025-173649OB-I00

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Ramy czasowe udostępniania IPD

5 years after publishing the data

Kryteria dostępu do udostępniania IPD

Everybody

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .