An interventional study of Morning exercise group and Evening exercise group in Metabolic Dysfunction-Associated Steatotic Liver Disease, Cardiometabolic Diseases and Exercise, sponsored by Universidad de Almeria. Not yet recruiting at 1 site in Spain. Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment
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:
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 63 is close to the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Universidad de Almeria is the lead sponsor of 72 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Usual-care control group
Behavioral: Morning exercise group
Behavioral: Evening exercise group
Participants perform supervised exercise sessions at 07:00h
Participants perform supervised exercise sessions at 19:00h
Participants receive lifestyle recommendations without exercise
Hepatic fat content
Hepatic fat content will be quantified using MRI
Time frame: Change from baseline in the mean adipose tissue content at 12 weeks
Visceral adipose tissue
Visceral adipose tissue will be quantified using MRI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Change from baseline in the energy metabolism related parameters at 12 weeks
Cardiorespiratory Fitness
VO₂max will be assessed following an incremental test to exhaustion.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: Change from baseline in the body weight at 12 weeks
Height
Height (in m) will be assessed using a stadiometer.
Time frame: 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
Time frame: Change from baseline in the height at 12 weeks
Fasting glucose levels
Fasting blood samples will be analyzed to determine glucose levels (mg/dl).
Time frame: 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).
Time frame: 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).
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
Fasting blood samples will be analyzed to determine cholesterol, HDL, and LDL levels (mg/dl).
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline in the questionnaire score at 12 weeks
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