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

17. september 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Borja Martínez Téllez, PhD
  • Telefonnummer: +34 950215334
  • E-post: borjammt@ual.es

Studiesteder

    • Almería
      • Almería, Almería, Spania, 04131
        • Universidad de Almería

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control

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

Eksperimentell: 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.

Eksperimentell: 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.

Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
iBAT adipocyte composition and gene expression (snRNA-seq)
Tidsramme: 1 week

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

1 week

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
iBAT mitochondrial respiration (Oroboros O2k).
Tidsramme: 1 week

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

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

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

5 weeks
Body Fat Percentage
Tidsramme: 5 weeks

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

5 weeks
Resting Metabolic Rate
Tidsramme: 5 weeks

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

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

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

5 weeks
Urinary Urea Nitrogen
Tidsramme: 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
Tidsramme: 5 weeks

Change in gut microbiota composition assessed in fecal samples.

5 weeks
Fat-Free Mass
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 5 weeks

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

5 weeks
Fasting Glucose
Tidsramme: 5 weeks

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

5 weeks
Fasting Insulin
Tidsramme: 5 weeks

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

5 weeks
Triglycerides
Tidsramme: 5 weeks

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

5 weeks
C-Reactive Protein (CRP)
Tidsramme: 5 weeks

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

5 weeks
Fat Oxidation During Exercise
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2027

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

9. september 2026

Først innsendt som oppfylte QC-kriteriene

17. september 2026

Først lagt ut (Faktiske)

23. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

5 years after publishing the data

Tilgangskriterier for IPD-deling

Everybody

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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