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

NCT07386665 | Not Yet Recruiting

• 1 other identifier: UALBIO2025/008
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiometabolic Diseases; Exercise; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Exercise; Metabolism; Health; Women

Outcome Measures

Primary Outcomes (1)

• Hepatic fat content

  Hepatic fat content will be quantified using MRI

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

Secondary Outcomes (26)

• Visceral adipose tissue

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

• Intra-muscular adipose tissue

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

• Body composition

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

• Bone related parameters

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

• Resting blood pressure

  Change from baseline in the resting blood pressure related parameters at 12 weeks

Study Arms (3)

Usual-Care Control Group

PLACEBO COMPARATOR

Behavioral: Usual-care control group

Morning Exercise Group

EXPERIMENTAL

Behavioral: Morning exercise group

Evening Exercise Group

EXPERIMENTAL

Behavioral: Evening exercise group

Interventions

Evening exercise group BEHAVIORAL

Participants perform supervised exercise sessions at 19:00h

Evening Exercise Group

Usual-care control group BEHAVIORAL

Participants receive lifestyle recommendations without exercise

Usual-Care Control Group

Morning exercise group BEHAVIORAL

Participants perform supervised exercise sessions at 07:00h

Morning Exercise Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Universidad de Almería

Almería, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Ramón y Cajal

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: February 4, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-01

Locations

ES (1)