Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07386665
Impact of Circadian Exercise on Metabolic Dysfunction-Associated Steatotic Liver Disease in Postmenopausal Women
A study testing Morning exercise group and Evening exercise group in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Cardiometabolic Diseases, run by Universidad de Almeria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Cardiometabolic Diseases, Exercise
- What is being tested?
- Morning exercise group and Evening exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad de Almería
Almería
Juan M. A. Alcantara, Ph.D., +34, alcantarajma@ual.es
About this study
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.
Read more
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.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately one in three adults and is a major contributor to the growing burden of cardiometabolic disease. Exercise is one of the most effective interventions for improving cardiometabolic health, reducing hepatic fat, and enhancing metabolic flexibility. However, the timing of exercise -a modifiable behavioral factor- may play a crucial yet underexplored role in determining its physiological benefits.
Preclinical studies have shown that circadian rhythms regulate key metabolic processes, including lipid metabolism and glucose homeostasis. Moreover, recent findings suggest that exercise performed at different times of day may elicit different responses, influencing the regulation of hepatic fat and systemic inflammation. These effects may be mediated, in part, through gut microbiota, which modulate host metabolism via the gut-liver axis. However, the interaction between exercise timing and gut microbiota in human physiology -particularly in women- remains poorly understood.
This knowledge gap is particularly critical in postmenopausal women, a population that experiences profound metabolic changes due to hormonal decline, including increased hepatic and visceral fat, chronic inflammation, and reduced insulin sensitivity. These alterations significantly elevate the risk for MASLD and other cardiometabolic diseases. Yet, postmenopausal women are consistently underrepresented in clinical trials exploring exercise interventions.
Based on emerging scientific evidence, the investigators hypothesize that morning exercise may lead to greater reductions in hepatic fat and improvements in cardiometabolic health compared to evening exercise in postmenopausal women with MASLD. Furthermore, the investigators propose that these effects may be partially mediated by exercise-induced changes in gut microbiota composition and function.
Thus, the main objective of the project is to investigate whether the timing of exercise modulates hepatic fat reduction, cardiometabolic adaptation, and gut microbiota remodeling in postmenopausal women with MASLD. To achieve this, the project will implement a randomized controlled trial in which 63 sedentary postmenopausal women diagnosed with MASLD will be randomly allocated into one of three groups: (i) morning exercise (07:00h), (ii) evening exercise (19:00h), or (iii) a usual-care control group receiving lifestyle recommendations.
Participants in the intervention groups will complete a 12-week supervised training program, combining aerobic and resistance exercise (3 sessions/week, 60-90 minutes per session), in accordance with WHO recommendations. Before and after the intervention, biological samples, magnetic resonance imaging, and metabolic assessments will be collected. The study will employ advanced multi-omics analyses, including metabolomics and semi-targeted metagenomics, to explore how gut microbiota changes relate to improvements in metabolism.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Cardiometabolic Diseases, Exercise
- Being tested
- Morning exercise group, Evening exercise group, Usual-care control group
- Keywords
- Exercise, Metabolism, Health, Women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning exercise groupBehavioural
Participants perform supervised exercise sessions at 07:00h
Evening exercise groupBehavioural
Participants perform supervised exercise sessions at 19:00h
Usual-care control groupBehavioural
Participants receive lifestyle recommendations without exercise
| Study group | Role | What they receive |
|---|---|---|
| Usual-Care Control Group | Placebo comparator | Not described Receives: Behavioral: Usual-care control group |
| Morning Exercise Group | Experimental | Not described Receives: Behavioral: Morning exercise group |
| Evening Exercise Group | Experimental | Not described Receives: Behavioral: Evening exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fat content
Hepatic fat content will be quantified using MRI
Measured: Change from baseline in the mean adipose tissue content at 12 weeks
Secondary outcomes (29)
Visceral adipose tissue
Visceral adipose tissue will be quantified using MRI
Measured: Change from baseline in the mean adipose tissue content at 12 weeks
Intra-muscular adipose tissue
Intra-muscular adipose tissue, at the mid thigh, will be quantified using MRI
Measured: Change from baseline in the mean adipose tissue content at 12 weeks
Body composition
Whole-body composition will be quantified using DXA. Fat mass (in kg), and lean mass (in kg) will be assessed
Measured: Change from baseline in the whole-body composition at 12 weeks
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
Measured: Change from baseline in the whole-body mineral density and content at 12 weeks
Resting blood pressure
Systolic pressure (mmHg) and diastolic pressure (mmHg) will be measured.
Measured: Change from baseline in the resting blood pressure related parameters at 12 weeks
Glucose metabolism
Glucose metabolism (mg/dl) will be assessed via an oral glucose tolerance test with serial glucose measurements. Continuous glucose monitoring systems will be used to monitor 24-hour glycemic fluctuations (mg/dl) under free-living conditions
Measured: Change from baseline in the glucose related parameters at 12 weeks
Energy metabolism
Resting energy expenditure and exchange ratio will be determined using indirect calorimetry. Exercise energy expenditure and exchange ratio will be assessed during a steady-state submaximal exercise at 40-60% of VO2max
Measured: Change from baseline in the energy metabolism related parameters at 12 weeks
Cardiorespiratory Fitness
VO₂max will be assessed following an incremental test to exhaustion.
Measured: Change from baseline in the cardiorespiratory fitness at 12 weeks
Muscular strength
Muscular strength will be evaluated using 1-RM and/or maximal isometric strength tests for both upper and lower body strength.
Measured: Change from baseline in the muscular strength related parameters at 12 weeks
30 seconds sit-to-stand test
The 30-s sit-to-stand test will be conducted for evaluating the functional physical fitness (lower body strenth).
Measured: Change from baseline in the sit-to-stand related parameters at 12 weeks
Heart rate and heart rate variability
Heart rate (maximum and minimum values) and heart rate variability will be assessed at both, rest and exercise periods
Measured: Change from baseline in the heart rate and heart rate variability related parameters at 12 weeks
Body weight
Body weight (in kg) will be assessed using a scale.
Measured: Change from baseline in the body weight at 12 weeks
Height
Height (in m) will be assessed using a stadiometer.
Measured: Change from baseline in the height at 12 weeks
Body mass index
Body weight (in kg) and height (in m) will be combined to report BMI in kg/m^2
Measured: Change from baseline in the height at 12 weeks
Fasting glucose levels
Fasting blood samples will be analyzed to determine glucose levels (mg/dl).
Measured: Change from baseline in the fasting glucose levels at 12 weeks
Fasting insulin levels
Fasting blood samples will be analyzed to determine insulin levels (µmol/L).
Measured: Change from baseline in the fasting insulin levels at 12 weeks
Fasting HbA1c levels
Fasting blood samples will be analyzed to determine HbA1c levels (mmol/mol).
Measured: Change from baseline in the fasting HbA1c levels at 12 weeks
Fasting cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels
Fasting blood samples will be analyzed to determine cholesterol, HDL, and LDL levels (mg/dl).
Measured: Change from baseline in the fasting cholesterol, HDL, and LDL levels at 12 weeks
Relative abundance of specific bacterial taxa - fecal microbiota composition
Fecal samples will be collected before and after the exercise intervention to analyze the composition of the fecal microbiota. Percentage of total sequences assigned to specific taxa (e.g., Firmicutes, Bacteroidetes, Akkermansia) will be determined, and results will be expressed as percentage of total sequences (i.e., %) and/or relative abundance (i.e., proportion).
Measured: Change from baseline in the fecal microbiota at 12 weeks
Alpha diversity of the fecal microbiota - fecal microbiota diversity
Fecal samples will be collected before and after the exercise intervention to analyze the diversity of the fecal microbiota. Assessment of microbial richness and evenness within each sample will be determined, and results will be expressed as score on the Shannon Index / Simpson Index / observed OTUs.
Measured: Change from baseline in the fecal microbiota at 12 weeks
Concentration of specific metabolites - fecal microbiota function
Fecal samples will be collected before and after the exercise intervention to analyze the functional profile of the fecal microbiota (i.e., the concentration of metabolites). Quantification of metabolites (e.g., short-chain fatty acids [SCFAs]) will be determined, and results will be expressed as micromoles per gram of feces, millimolar, counts per million, or relative abundance of functional genes.
Measured: Change from baseline in the fecal microbiota at 12 weeks
International Physical Activity Questionnaire
The International Physical Activity Questionnaire (IPAQ) will be used for quantifying total physical activity in Metabolic Equivalent of Task-minutes per week (MET-min/week). In this questionnaire, a higher score indicates a greater volume of physical activity
Measured: Change from baseline in the questionnaire score at 12 weeks
Morningness-Eveningness Questionnaire
The Morningness-Eveningness Questionnaire (MEQ) will be used for determining the individual's circadian typology. In this questionnaire, a higher score indicates a stronger "morning-type" preference and a lower score signifies an "evening-type" preference
Measured: Change from baseline in the questionnaire score at 12 weeks
Pittsburgh Sleep Quality Index Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess subjective sleep quality and disturbances over a one-month period. In this questionnaire, a higher score represents poorer sleep quality; a score exceeding 5 typically denotes clinically poor global sleep quality. Additionally, participants will complete a sleep diary to record their daily sleep patterns and determine the actual hours of rest.
Measured: Change from baseline in the questionnaire score at 12 weeks
Three-Factor Eating Questionnaire
The Three-Factor Eating Questionnaire (TFEQ) or TFEQ-R18 will be used for measuring three components of eating behavior (Cognitive Restraint, Emotional Eating, and Uncontrolled Eating). In this questionnaire, elevated subscale scores indicate more disordered or problematic eating patterns
Measured: Change from baseline in the questionnaire score at 12 weeks
Perceived Stress Scale Questionnaire
The Perceived Stress Scale (PSS) will be used for measuring the degree to which life situations are appraised as stressful. In this questionnaire, a higher total score indicates a higher level of perceived psychological stress
Measured: Change from baseline in the questionnaire score at 12 weeks
Depression, Anxiety, and Stress Scale Questionnaire
The Depression, Anxiety, and Stress Scale (DASS-21) will be used for providing three independent severity subscales (Depression, Anxiety, and Stress). In this questionnaire, an increased score on any subscale signifies a greater severity of symptomatology and a diminished mental health status
Measured: Change from baseline in the questionnaire score at 12 weeks
Beck Depression Inventory Questionnaire
The Beck Depression Inventory (BDI-II) will be used for measuring depressive symptom severity. In this questionnaire, a higher score correlates directly with greater depressive symptom severity
Measured: Change from baseline in the questionnaire score at 12 weeks
Profile of Mood States Questionnaire
The Profile of Mood States (POMS) will be used for assessing transient mood states. In this questionnaire, higher scores on negative subscales indicate a poorer mood state, while an increased score on the Vigor scale indicates a more favorable mood
Measured: Change from baseline in the questionnaire score at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Manuel Alcantara Alcantara, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386665
- Sponsor's protocol ID
- UALBIO2025/008
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circadian Exercise on Metabolic Dysfunction-Associated Steatotic Liver Disease in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07386665
- Acronym / sponsor ID
- UALBIO2025/008
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Cardiometabolic Diseases, Exercise
- Keywords
- Exercise, Metabolism, Health, Women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) affects approximately one in three adults and is a major contributor to the growing burden of cardiometabolic disease. Exercise is one of the most effective interventions for improving cardiometabolic health, reducing hepatic fat, and enhancing metabolic flexibility. However, the timing of exercise -a modifiable behavioral factor- may play a crucial yet underexplored role in determining its physiological benefits.
Preclinical studies have shown that circadian rhythms regulate key metabolic processes, including lipid metabolism and glucose homeostasis. Moreover, recent findings suggest that exercise performed at different times of day may elicit different responses, influencing the regulation of hepatic fat and systemic inflammation. These effects may be mediated, in part, through gut microbiota, which modulate host metabolism via the gut-liver axis. However, the interaction between exercise timing and gut microbiota in human physiology -particularly in women- remains poorly understood.
This knowledge gap is particularly critical in postmenopausal women, a population that experiences profound metabolic changes due to hormonal decline, including increased hepatic and visceral fat, chronic inflammation, and reduced insulin sensitivity. These alterations significantly elevate the risk for MASLD and other cardiometabolic diseases. Yet, postmenopausal women are consistently underrepresented in clinical trials exploring exercise interventions.
Based on emerging scientific evidence, the investigators hypothesize that morning exercise may lead to greater reductions in hepatic fat and improvements in cardiometabolic health compared to evening exercise in postmenopausal women with MASLD. Furthermore, the investigators propose that these effects may be partially mediated by exercise-induced changes in gut microbiota composition and function.
Thus, the main objective of the project is to investigate whether the timing of exercise modulates hepatic fat reduction, cardiometabolic adaptation, and gut microbiota remodeling in postmenopausal women with MASLD. To achieve this, the project will implement a randomized controlled trial in which 63 sedentary postmenopausal women diagnosed with MASLD will be randomly allocated into one of three groups: (i) morning exercise (07:00h), (ii) evening exercise (19:00h), or (iii) a usual-care control group receiving lifestyle recommendations.
Participants in the intervention groups will complete a 12-week supervised training program, combining aerobic and resistance exercise (3 sessions/week, 60-90 minutes per session), in accordance with WHO recommendations. Before and after the intervention, biological samples, magnetic resonance imaging, and metabolic assessments will be collected. The study will employ advanced multi-omics analyses, including metabolomics and semi-targeted metagenomics, to explore how gut microbiota changes relate to improvements in metabolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning exercise groupParticipants perform supervised exercise sessions at 07:00h | Behavioural | Morning Exercise Group |
| Evening exercise groupParticipants perform supervised exercise sessions at 19:00h | Behavioural | Evening Exercise Group |
| Usual-care control groupParticipants receive lifestyle recommendations without exercise | Behavioural | Usual-Care Control Group |
Primary outcome
Hepatic fat content
Time frame: Change from baseline in the mean adipose tissue content at 12 weeks
Hepatic fat content will be quantified using MRI
29 secondary outcomes
Visceral adipose tissue
Time frame: Change from baseline in the mean adipose tissue content at 12 weeks
Intra-muscular adipose tissue
Time frame: Change from baseline in the mean adipose tissue content at 12 weeks
Body composition
Time frame: Change from baseline in the whole-body composition at 12 weeks
Bone related parameters
Time frame: Change from baseline in the whole-body mineral density and content at 12 weeks
Resting blood pressure
Time frame: Change from baseline in the resting blood pressure related parameters at 12 weeks
Glucose metabolism
Time frame: Change from baseline in the glucose related parameters at 12 weeks
Energy metabolism
Time frame: Change from baseline in the energy metabolism related parameters at 12 weeks
Cardiorespiratory Fitness
Time frame: Change from baseline in the cardiorespiratory fitness at 12 weeks
Muscular strength
Time frame: Change from baseline in the muscular strength related parameters at 12 weeks
30 seconds sit-to-stand test
Time frame: Change from baseline in the sit-to-stand related parameters at 12 weeks
Heart rate and heart rate variability
Time frame: Change from baseline in the heart rate and heart rate variability related parameters at 12 weeks
Body weight
Time frame: Change from baseline in the body weight at 12 weeks
Height
Time frame: Change from baseline in the height at 12 weeks
Body mass index
Time frame: Change from baseline in the height at 12 weeks
Fasting glucose levels
Time frame: Change from baseline in the fasting glucose levels at 12 weeks
Fasting insulin levels
Time frame: Change from baseline in the fasting insulin levels at 12 weeks
Fasting HbA1c levels
Time frame: Change from baseline in the fasting HbA1c levels at 12 weeks
Fasting cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels
Time frame: Change from baseline in the fasting cholesterol, HDL, and LDL levels at 12 weeks
Relative abundance of specific bacterial taxa - fecal microbiota composition
Time frame: Change from baseline in the fecal microbiota at 12 weeks
Alpha diversity of the fecal microbiota - fecal microbiota diversity
Time frame: Change from baseline in the fecal microbiota at 12 weeks
Concentration of specific metabolites - fecal microbiota function
Time frame: Change from baseline in the fecal microbiota at 12 weeks
International Physical Activity Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Morningness-Eveningness Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Pittsburgh Sleep Quality Index Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Three-Factor Eating Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Perceived Stress Scale Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Depression, Anxiety, and Stress Scale Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Beck Depression Inventory Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Profile of Mood States Questionnaire
Time frame: Change from baseline in the questionnaire score at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning exercise group and Evening exercise group in people with Metabolic Dysfunction-Associated Steatotic Liver Disease and Cardiometabolic Diseases, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic fat content (time frame: Change from baseline in the mean adipose tissue content at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.