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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Morning exercise group
BehavioralParticipants perform supervised exercise sessions at 07:00h
Evening exercise group
BehavioralParticipants perform supervised exercise sessions at 19:00h
Usual-care control group
BehavioralParticipants receive lifestyle recommendations without exercise
Treatment groups
Trial outcomes
Primary outcomes
Hepatic fat content
Hepatic fat content will be quantified using MRI
Secondary outcomes
Visceral adipose tissue
Visceral adipose tissue will be quantified using MRI
Intra-muscular adipose tissue
Intra-muscular adipose tissue, at the mid thigh, will be quantified using MRI
Body composition
Whole-body composition will be quantified using DXA. Fat mass (in kg), and lean mass (in kg) will be assessed
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
Sponsors and contacts
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