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Clinical Trials in Spain / NCT07386665
Starting soon Not applicable

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

NCT07386665 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-05-08

Condition(s) studied

Metabolic Dysfunction-Associated Steatotic Liver DiseaseCardiometabolic DiseasesExercise

Investigational drug(s) / intervention(s)

Morning exercise groupEvening exercise groupUsual-care control group

Morning exercise group: Participants perform supervised exercise sessions at 07:00h

Evening exercise group: Participants perform supervised exercise sessions at 19:00h

Usual-care control group: Participants receive lifestyle recommendations without exercise

Study 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.

Eligibility

Sex
FEMALE
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
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 programs or special diets (e.g., ketogenic, high-carb) * Shift workers or caregivers with frequent nocturnal disruptions

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universidad de Almería Almería Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07386665 on ClinicalTrials.gov ↗ ← All trials in Spain