HormoneNCT07264348
Cardiometabolic and Hormonal Adaptations to 4-Month Zumba Training in Overweight/Obese Women
A study testing Zumba training in people with Hormone and Cardiovascular, run by High Institute of Sports and Physical Education of Kef.
Trial summary
This study aims to evaluate the effects of a 4 month Zumba training program on cardiometabolic, hormonal, inflammatory, hepatic, renal, and functional parameters in overweight and obese women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hormone, Cardiovascular, Obesity & Overweight
- What is being tested?
- Zumba training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 15 Apr 2026
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18-65 years
- BMI ≥ 25 kg/m²
- Pre-menopausal or post-menopausal (classified clinically)
- Voluntary written informed consent
Who cannot join
- Hormonal therapy or weight-loss medications
- Endocrine diseases or chronic illness
- Recent intense physical training (<48 hours before baseline)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
wissal Abassi, Dr contact
About this study
Official title: Effects of a 4-month Intervention on Cardiometabolic, Hormonal, Inflammatory, Liver, Renal, Electrolyte, and Muscle Enzyme Parameters in Pre- and Post-Menopausal Overweight and Obese Women: A Randomized Controlled Trial
This study aims to evaluate the effects of a 4 month Zumba training program on cardiometabolic, hormonal, inflammatory, hepatic, renal, and functional parameters in overweight and obese women. Participants will be classified according to menopausal status (pre- or post-menopausal) and randomly assigned to an exercise group or a non-exercise control group.
Read the detailed description
Overweight and obesity are associated with metabolic dysregulation, hormonal imbalance, chronic inflammation, and reduced physical capacity. Zumba training is a dance-based aerobic exercise that can improve cardiovascular fitness, energy expenditure, and adherence to physical activity programs.
This study will assess the effects of a 4 month Zumba training program (4 sessions per week, 60 minutes per session) on: Body composition and anthropometric measures, Aerobic capacity, Hormonal profile, Lipid profile, Inflammatory biomarkers, Liver enzymes, Renal function markers, Electrolytes, Muscle enzymes, Pre- and post-training measurements will be taken under standardized conditions.
- Conditions
- Hormone, Cardiovascular, Obesity & Overweight
- Being tested
- Zumba training
- Keywords
- Overweight, Obesity, Pre-menopause, Post-menopause, Zumba Training, Cardiometabolic Health, Hormonal Adaptations, Lipid Profile
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zumba trainingBehavioural
Participants assigned to the experimental groups will perform a supervised Zumba training program for 10 weeks, with 4 sessions per week, each session lasting 60 minutes. Sessions will include a standardized warm-up (10 minutes), choreographed dance-based aerobic sequences performed at moderate intensity (40 minutes), and a cool-down with stretching (10 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1:Pre-menopausal | Experimental | performed Zumba training, 4 × 60 min/week, 4 months Receives: Behavioral: Zumba training |
| Control Group 1 | No intervention | No training intervention was intended for the control group. |
| Experimental Group 2:Post-menopausal | Experimental | performed Zumba training, 4 × 60 min/week, 4 months Receives: Behavioral: Zumba training |
| Control group 2 | No intervention | No training intervention was intended for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²).
Measured: Baseline and after 4 months of Zumba intervention.
Body Fat Percentage
Total body fat measured by digital scale (Tanita BC-533).
Measured: Baseline and after 4 months of Zumba intervention.
Waist Circumference
Measured at the narrowest point between the rib cage and iliac crest using a tape measure.
Measured: Baseline and after 4 months of Zumba intervention.
Waist-Hip Ratio
Calculated by dividing waist circumference by hip circumference.
Measured: Baseline and after 4 months of Zumba intervention.
Hip Circumference
Measured at the widest point of the hips using a tape measure.
Measured: Baseline and after 4 months of Zumba intervention.
Prolactin
Serum prolactin concentration (ng/mL).
Measured: Baseline and after 4 months of the intervention.
Testosterone
Serum testosterone concentration (ng/dL).
Measured: Baseline and after 4 months of the intervention.
Cortisol
Serum cortisol concentration (µg/dL).
Measured: Baseline and after 4 months of the intervention.
Progesterone
Serum progesterone concentration (ng/mL).
Measured: Baseline and after 4 months of the intervention.
Estradiol
Serum estradiol concentration (pg/mL).
Measured: Baseline and after 4 months of the intervention.
Follicle-Stimulating Hormone (FSH)
Serum FSH concentration (mIU/mL).
Measured: Baseline and after 4 months of the intervention.
Luteinizing Hormone (LH)
Serum LH concentration (mIU/mL).
Measured: Baseline and after 4 months of the intervention.
Thyroid Stimulating Hormone (TSH)
Serum TSH concentration (µIU/mL).
Measured: Baseline and after 4 months of the intervention.
Free Thyroxine (FT4)
Serum free T4 concentration (ng/dL).
Measured: Baseline and after 4 months of the intervention.
Parathyroid Hormone (PTH)
Serum PTH concentration (pg/mL).
Measured: Baseline and after 4 months of the intervention.
Total Cholesterol
Serum total cholesterol concentration (mg/dL).
Measured: Baseline and after 4 months of the intervention.
High-Density Lipoprotein (HDL) Cholesterol
Serum HDL cholesterol concentration (mg/dL).
Measured: Baseline and after 4 months of the intervention.
Low-Density Lipoprotein (LDL) Cholesterol
Serum LDL cholesterol concentration (mg/dL).
Measured: Baseline and after 4 months of the intervention.
Triglycerides
Serum triglyceride concentration (mg/dL).
Measured: Baseline and after 4 months of the intervention.
C-Reactive Protein (CRP)
Serum CRP concentration (mg/L).
Measured: Baseline and after 4 months of the intervention.
Erythrocyte Sedimentation Rate (ESR)
ESR measured in mm/hr.
Measured: Baseline and after 4 months of the intervention.
Complete Blood Count (CBC)
Includes neutrophils, lymphocytes, monocytes, eosinophils, basophils (cells/µL).
Measured: Baseline and after 4 months of the intervention.
Alanine Aminotransferase (ALT)
Serum ALT concentration measured in U/L.
Measured: Baseline and after 4 months of the intervention.
Aspartate Aminotransferase (AST)
Serum AST concentration measured in U/L.
Measured: Baseline and after 4 months of the intervention.
Alkaline Phosphatase (ALP)
Serum ALP concentration measured in U/L.
Measured: Baseline and after 4 months of the intervention.
Gamma-Glutamyl Transferase (GGT)
Serum GGT concentration measured in U/L.
Measured: Baseline and after 4 months of the intervention.
Lactate Dehydrogenase (LDH)
Serum LDH concentration measured in U/L.
Measured: Baseline and after the 4 months of the intervention.
Gamma-Glutamyl Transferase (GGT)
Serum GGT concentration measured in U/L.
Measured: Baseline and after the 4 months of the intervention.
Bilirubin Total
Total serum bilirubin concentration measured in mg/dL.
Measured: Baseline and after the 4 months of the intervention.
Bilirubin Direct
Direct (conjugated) serum bilirubin concentration measured in mg/dL.
Measured: Baseline and after the 4 months of the intervention.
Creatinine
Serum creatinine concentration measured in mg/dL, indicator of kidney function.
Measured: Baseline and after 4 months of the intervention.
Urea
Serum urea concentration measured in mg/dL, indicator of kidney function.
Measured: Baseline and after 4 months of the intervention.
Uric Acid
Serum uric acid concentration measured in mg/dL, indicator of kidney function.
Measured: Baseline and after 4 months of the intervention.
Sodium (Na)
Serum sodium concentration measured in mmol/L.
Measured: Baseline and after 4 months of the intervention.
Potassium (K)
Serum potassium concentration measured in mmol/L.
Measured: Baseline and after 4 months of the intervention.
Calcium (Ca)
Serum calcium concentration measured in mg/dL.
Measured: Baseline and after 4 months of training.
Magnesium (Mg)
Serum magnesium concentration measured in mg/dL.
Measured: Baseline and after 4 months of training.
Phosphate (PO₄)
Serum phosphate concentration measured in mg/dL.
Measured: Baseline and after 4 months of training.
Creatine Phosphokinase (CPK)
Serum CPK concentration measured in U/L, indicator of muscle damage.
Measured: Baseline and after 4 months of training.
Lactate Dehydrogenase (LDH)
Serum LDH concentration measured in U/L, indicator of muscle and tissue damage.
Measured: Baseline and after 4 months of training.
Secondary outcomes (3)
Resting Heart Rate
Measured using automated device (Omron BP652).
Measured: Baseline and after 4 months of Zumba intervention.
Blood Pressure (Systolic and Diastolic)
Measured using an automated arm cuff (Omron BP652).
Measured: Baseline and after 4 months of Zumba intervention.
6-Minute Walk Test (6MWT) Distance
Distance walked in 6 minutes on a 30-meter straight corridor.
Measured: Baseline and after 4 months of Zumba intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HormoneStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
- Investigators
- Wissal abassi, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264348
- Sponsor's protocol ID
- HORMONE-2025
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 4-month Intervention on Cardiometabolic, Hormonal, Inflammatory, Liver, Renal, Electrolyte, and Muscle Enzyme Parameters in Pre- and Post-Menopausal Overweight and Obese Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264348
- Acronym / sponsor ID
- HORMONE-2025
- Conditions
- Hormone, Cardiovascular, Obesity & Overweight
- Keywords
- Overweight, Obesity, Pre-menopause, Post-menopause, Zumba Training, Cardiometabolic Health, Hormonal Adaptations, Lipid Profile
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
This study aims to evaluate the effects of a 4 month Zumba training program on cardiometabolic, hormonal, inflammatory, hepatic, renal, and functional parameters in overweight and obese women. Participants will be classified according to menopausal status (pre- or post-menopausal) and randomly assigned to an exercise group or a non-exercise control group.
Detailed description
Overweight and obesity are associated with metabolic dysregulation, hormonal imbalance, chronic inflammation, and reduced physical capacity. Zumba training is a dance-based aerobic exercise that can improve cardiovascular fitness, energy expenditure, and adherence to physical activity programs.
This study will assess the effects of a 4 month Zumba training program (4 sessions per week, 60 minutes per session) on: Body composition and anthropometric measures, Aerobic capacity, Hormonal profile, Lipid profile, Inflammatory biomarkers, Liver enzymes, Renal function markers, Electrolytes, Muscle enzymes, Pre- and post-training measurements will be taken under standardized conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1:Pre-menopausal | Experimental | Behavioral: Zumba trainingperformed Zumba training, 4 × 60 min/week, 4 months |
| Control Group 1 | No intervention | –No training intervention was intended for the control group. |
| Experimental Group 2:Post-menopausal | Experimental | Behavioral: Zumba trainingperformed Zumba training, 4 × 60 min/week, 4 months |
| Control group 2 | No intervention | –No training intervention was intended for the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, aged 18-65 years
- BMI ≥ 25 kg/m²
- Pre-menopausal or post-menopausal (classified clinically)
- Voluntary written informed consent
Key exclusion criteria (3 listed)
- Hormonal therapy or weight-loss medications
- Endocrine diseases or chronic illness
- Recent intense physical training (<48 hours before baseline)
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 |
|---|---|---|
| Zumba trainingParticipants assigned to the experimental groups will perform a supervised Zumba training program for 10 weeks, with 4 sessions per week, each session lasting 60 minutes. Sessions will include a standardized warm-up (10 minutes), choreographed dance-based aerobic sequences performed at moderate intensity (40 minutes), and a cool-down with stretching (10 minutes). | Behavioural | Experimental Group 1:Pre-menopausal, Experimental Group 2:Post-menopausal |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline and after 4 months of Zumba intervention.
BMI calculated as weight (kg) divided by height squared (m²).
Body Fat Percentage
Time frame: Baseline and after 4 months of Zumba intervention.
Total body fat measured by digital scale (Tanita BC-533).
Waist Circumference
Time frame: Baseline and after 4 months of Zumba intervention.
Measured at the narrowest point between the rib cage and iliac crest using a tape measure.
Waist-Hip Ratio
Time frame: Baseline and after 4 months of Zumba intervention.
Calculated by dividing waist circumference by hip circumference.
Hip Circumference
Time frame: Baseline and after 4 months of Zumba intervention.
Measured at the widest point of the hips using a tape measure.
Prolactin
Time frame: Baseline and after 4 months of the intervention.
Serum prolactin concentration (ng/mL).
Testosterone
Time frame: Baseline and after 4 months of the intervention.
Serum testosterone concentration (ng/dL).
Cortisol
Time frame: Baseline and after 4 months of the intervention.
Serum cortisol concentration (µg/dL).
Progesterone
Time frame: Baseline and after 4 months of the intervention.
Serum progesterone concentration (ng/mL).
Estradiol
Time frame: Baseline and after 4 months of the intervention.
Serum estradiol concentration (pg/mL).
Follicle-Stimulating Hormone (FSH)
Time frame: Baseline and after 4 months of the intervention.
Serum FSH concentration (mIU/mL).
Luteinizing Hormone (LH)
Time frame: Baseline and after 4 months of the intervention.
Serum LH concentration (mIU/mL).
Thyroid Stimulating Hormone (TSH)
Time frame: Baseline and after 4 months of the intervention.
Serum TSH concentration (µIU/mL).
Free Thyroxine (FT4)
Time frame: Baseline and after 4 months of the intervention.
Serum free T4 concentration (ng/dL).
Parathyroid Hormone (PTH)
Time frame: Baseline and after 4 months of the intervention.
Serum PTH concentration (pg/mL).
Total Cholesterol
Time frame: Baseline and after 4 months of the intervention.
Serum total cholesterol concentration (mg/dL).
High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline and after 4 months of the intervention.
Serum HDL cholesterol concentration (mg/dL).
Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline and after 4 months of the intervention.
Serum LDL cholesterol concentration (mg/dL).
Triglycerides
Time frame: Baseline and after 4 months of the intervention.
Serum triglyceride concentration (mg/dL).
C-Reactive Protein (CRP)
Time frame: Baseline and after 4 months of the intervention.
Serum CRP concentration (mg/L).
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and after 4 months of the intervention.
ESR measured in mm/hr.
Complete Blood Count (CBC)
Time frame: Baseline and after 4 months of the intervention.
Includes neutrophils, lymphocytes, monocytes, eosinophils, basophils (cells/µL).
Alanine Aminotransferase (ALT)
Time frame: Baseline and after 4 months of the intervention.
Serum ALT concentration measured in U/L.
Aspartate Aminotransferase (AST)
Time frame: Baseline and after 4 months of the intervention.
Serum AST concentration measured in U/L.
Alkaline Phosphatase (ALP)
Time frame: Baseline and after 4 months of the intervention.
Serum ALP concentration measured in U/L.
Gamma-Glutamyl Transferase (GGT)
Time frame: Baseline and after 4 months of the intervention.
Serum GGT concentration measured in U/L.
Lactate Dehydrogenase (LDH)
Time frame: Baseline and after the 4 months of the intervention.
Serum LDH concentration measured in U/L.
Gamma-Glutamyl Transferase (GGT)
Time frame: Baseline and after the 4 months of the intervention.
Serum GGT concentration measured in U/L.
Bilirubin Total
Time frame: Baseline and after the 4 months of the intervention.
Total serum bilirubin concentration measured in mg/dL.
Bilirubin Direct
Time frame: Baseline and after the 4 months of the intervention.
Direct (conjugated) serum bilirubin concentration measured in mg/dL.
Creatinine
Time frame: Baseline and after 4 months of the intervention.
Serum creatinine concentration measured in mg/dL, indicator of kidney function.
Urea
Time frame: Baseline and after 4 months of the intervention.
Serum urea concentration measured in mg/dL, indicator of kidney function.
Uric Acid
Time frame: Baseline and after 4 months of the intervention.
Serum uric acid concentration measured in mg/dL, indicator of kidney function.
Sodium (Na)
Time frame: Baseline and after 4 months of the intervention.
Serum sodium concentration measured in mmol/L.
Potassium (K)
Time frame: Baseline and after 4 months of the intervention.
Serum potassium concentration measured in mmol/L.
Calcium (Ca)
Time frame: Baseline and after 4 months of training.
Serum calcium concentration measured in mg/dL.
Magnesium (Mg)
Time frame: Baseline and after 4 months of training.
Serum magnesium concentration measured in mg/dL.
Phosphate (PO₄)
Time frame: Baseline and after 4 months of training.
Serum phosphate concentration measured in mg/dL.
Creatine Phosphokinase (CPK)
Time frame: Baseline and after 4 months of training.
Serum CPK concentration measured in U/L, indicator of muscle damage.
Lactate Dehydrogenase (LDH)
Time frame: Baseline and after 4 months of training.
Serum LDH concentration measured in U/L, indicator of muscle and tissue damage.
3 secondary outcomes
Resting Heart Rate
Time frame: Baseline and after 4 months of Zumba intervention.
Blood Pressure (Systolic and Diastolic)
Time frame: Baseline and after 4 months of Zumba intervention.
6-Minute Walk Test (6MWT) Distance
Time frame: Baseline and after 4 months of Zumba intervention.
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 4 Dec 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study will be available upon request.
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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.
wissal Abassi, Dr contact
Wissal abassi principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
Questions about this trial
What is this clinical trial studying?
A study testing Zumba training in people with Hormone and Cardiovascular, run by High Institute of Sports and Physical Education of Kef.
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 4 inclusion and 3 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Wissal Abassi, Dr (+21693304684, wissalabassi93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Baseline and after 4 months of Zumba intervention.). The study lists 40 primary outcomes in all. 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 4 Dec 2025.