Not Yet RecruitingNot Applicable

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

Spain63 participantsStarted 2026-06-01

Plain-language summary

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.

Who can participate

Age range

45 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * Willingness to be randomized and adhere to study procedures, including all assessments and visits * Sufficient Spanish proficiency to understand and follow study instructions * Consent to store biological samples for future research * Participants should have a healthy circadian rhythm Exclusion Criteria: * 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 * Psychiatric, psychotic, eating, or sleep disorders (to be judged by the study physician) * Prior bariatric surgery, diagnosed HIV/AIDS, or inflammatory/autoimmune diseases * Cancer or any medical condition where exercise is contraindicated (to be judged by the study physician) * Recent or unstable metabolic conditions (e.g., diabetes, recent medication changes, or use of drugs affecting metabolism) * Recent (\<3 months) use of antibiotics, statins, glucocorticoids, hormonal therapies, amiodarone, or myelosuppressive agents * Participation in weight-loss…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hepatic fat content

Timeframe: Change from baseline in the mean adipose tissue content at 12 weeks

Trial details

NCT IDNCT07386665

SponsorUniversidad de Almeria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Metabolic Dysfunction-Associated Steatotic Liver Disease trials