Health TrialsbyHealthPanel

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

ConditionsCardiometabolic DiseasesPostmenopause
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorUniversidad de Almeria

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic exercise

    Behavioral

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

  • Prolonged fasting

    Behavioral

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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Aerobic exerciseExperimental treatment 1 intervention
Group C: Prolonged fastingExperimental treatment 1 intervention
Group D: Aerobic exercise + prolonged fastingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Time frame
1 week

Secondary outcomes

1

iBAT mitochondrial respiration (Oroboros O2k).

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

Time frame
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.

Time frame
1 week
3

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
4

Body Fat Percentage

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

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Almeria

Lead sponsor

Leiden University Medical Center

Collaborator

ETH Zurich (Switzerland)

Collaborator

Buchinger Wilhelmi Development & Holding GmbH

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: