Impact of Circadian Exercise on Metabolic Dysfunction-Associated Steatotic Liver Disease in Postmenopausal Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorUniversidad de Almeria

About this trial

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to investigate how performing exercise at different times of day (morning vs. evening) affects liver fat, cardiometabolic health, and gut microbiota in postmenopausal women.

Participant Population/Health Conditions: The study will involve 63 sedentary postmenopausal women (aged 45-75) diagnosed with metabolic dysfunction-associated steatotic liver disease.

Main Questions: The main questions this study aims to answer are:

* Does morning exercise reduce hepatic fat more effectively than evening exercise? * How does time-of-day-specific exercise influence cardiometabolic markers? * Do changes in gut microbiota contribute to the metabolic effects of exercise timing?

Participants Will:

Be randomized into one of three groups: morning exercise, evening exercise, or a usual-care control group.

Follow the assigned regimen for 12 weeks. The exercise groups will perform supervised aerobic and resistance training three times per week.

Provide blood, stool, and imaging data before and after the intervention to determine the effects of the intervention.

Comparison Group:

Researchers will compare the effects of morning vs. evening exercise (and usual care) on hepatic fat reduction and cardiometabolic improvement, as well as changes in gut microbiota.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 45-75 years, postmenopausal for at least two years (stage +1a)

Body Mass Index (BMI) > 25 and < 40 kg/m²

Diagnosed hepatic steatosis (via ultrasound hyperechogenicity, FibroScan CAP score >280, or histological confirmation)

Sedentary lifestyle (no regular structured exercise)

Disqualifiers

Contraindications for MRI (e.g., claustrophobia, pacemaker, metal implants)

History of major cardiovascular, endocrine, neurological, or kidney disease, or any clinical abnormalities (to be judged by the study physician)

First-degree family history of sudden cardiac death

Alcohol or substance abuse

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morning exercise group

    Behavioral

    Participants perform supervised exercise sessions at 07:00h

  • Evening exercise group

    Behavioral

    Participants perform supervised exercise sessions at 19:00h

  • Usual-care control group

    Behavioral

    Participants receive lifestyle recommendations without exercise

Treatment groups

63 Participants
are divided into 3 treatment groups
Group A: Usual-Care Control GroupPlacebo comparator 1 intervention
Group B: Morning Exercise GroupExperimental treatment 1 intervention
Group C: Evening Exercise GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hepatic fat content

Hepatic fat content will be quantified using MRI

Time frame
Change from baseline in the mean adipose tissue content at 12 weeks

Secondary outcomes

1

Visceral adipose tissue

Visceral adipose tissue will be quantified using MRI

Time frame
Change from baseline in the mean adipose tissue content at 12 weeks
2

Intra-muscular adipose tissue

Intra-muscular adipose tissue, at the mid thigh, will be quantified using MRI

Time frame
Change from baseline in the mean adipose tissue content at 12 weeks
3

Body composition

Whole-body composition will be quantified using DXA. Fat mass (in kg), and lean mass (in kg) will be assessed

Time frame
Change from baseline in the whole-body composition at 12 weeks
4

Bone related parameters

Whole-body bone related parameters will be quantified using DXA. Bone mineral density and content (both in g/cm\^2) will be assessed

Time frame
Change from baseline in the whole-body mineral density and content at 12 weeks

Other outcomes

Sponsors and contacts

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