ObesityNCT07750197
Exercise and Diet Responses in Adult Men With Obesity by MC4R Genotype and Metabolic Health
A study testing Supervised Aerobic and Resistance Exercise in people with Obesity and Metabolically Healthy Obesity, run by Harbin Sport University at 1 site in China.
Trial summary
This study evaluated whether differences in the MC4R rs17782313 gene variant and metabolic health status were associated with different responses to a 12-week exercise and dietary intervention in adult men with obesity. A total of 40 men aged 18 to 59 years with obesity participated in the study. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men only
- Conditions the study is for
- Obesity, Metabolically Healthy Obesity, Metabolically Unhealthy Obesity
- What is being tested?
- Supervised Aerobic and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male sex
- Age 18 to 59 years
- Body mass index of at least 28 kg/m2
- Waist circumference of at least 90 cm
- Able and willing to provide written informed consent
- Able and willing to participate in the 12-week supervised exercise and dietary intervention and complete the scheduled assessments
Who cannot join
- Severe hepatic insufficiency
- Severe renal insufficiency
- Cardiovascular disease
- Other clinically significant vascular disease
- Current use of glucose-lowering medication
- Current use of antihypertensive medication
- Current use of lipid-lowering medication
- Unable or unwilling to comply with the intervention and assessment schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of MC4R rs17782313 Polymorphism and Metabolic Phenotype With Responses to a 12-Week Combined Exercise and Dietary Intervention in Adult Men With Obesity
This study evaluated whether differences in the MC4R rs17782313 gene variant and metabolic health status were associated with different responses to a 12-week exercise and dietary intervention in adult men with obesity.
A total of 40 men aged 18 to 59 years with obesity participated in the study. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity according to metabolic risk factors. All participants received the same supervised lifestyle intervention, which included aerobic exercise, resistance training, and an individualized energy-controlled diet.
Body weight, body composition, physical fitness, blood pressure, blood glucose, blood lipids, glycated hemoglobin, and fasting insulin were measured before and after the 12-week intervention. Blood samples were also collected for MC4R rs17782313 genotyping. The study examined whether changes after the intervention differed according to baseline metabolic phenotype and MC4R genotype.
Read the detailed description
This was a completed, single-center lifestyle intervention study involving adult men with obesity in Harbin, China.
Eligible participants were men aged 18 to 59 years with a body mass index of at least 28 kg/m2 and a waist circumference of at least 90 cm. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity using criteria based on the National Cholesterol Education Program Adult Treatment Panel III.
Metabolically unhealthy obesity was defined as obesity accompanied by at least two of the following metabolic abnormalities: elevated blood pressure, elevated fasting blood glucose, elevated triglycerides, or reduced high-density lipoprotein cholesterol. Metabolically healthy obesity was defined as obesity accompanied by no more than one of these abnormalities.
All participants received the same 12-week supervised exercise and dietary intervention. The exercise program was conducted 5 days per week and consisted of aerobic exercise performed at approximately 60% to 70% of maximum heart rate and resistance exercise performed at approximately 40% to 60% of one-repetition maximum.
Daily energy intake was individualized according to standard body weight. The planned macronutrient distribution was approximately 50% to 60% of energy from carbohydrates, 15% to 20% from protein, and 20% to 30% from fat.
Anthropometric and body-composition assessments included body weight, body mass index, fat mass, body fat percentage, muscle mass, waist circumference, hip circumference, and waist-to-hip ratio. Physical fitness assessments included vital capacity, handgrip strength, vertical jump, push-ups, sit-ups, sit-and-reach flexibility, one-leg standing with eyes closed, choice reaction time, and back strength.
Physiological and biochemical assessments included resting heart rate, systolic and diastolic blood pressure, fasting blood glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, glycated hemoglobin, and fasting insulin. Measurements were conducted at baseline and after 12 weeks.
MC4R rs17782313 genotype and baseline metabolic phenotype were analytical stratification variables. They were not used to assign different interventions. The study evaluated changes from baseline to week 12 and examined whether intervention responses were associated with metabolic phenotype, MC4R genotype, or their interaction.
- Being tested
- Supervised Aerobic and Resistance Exercise
- Keywords
- MC4R, rs17782313, Single Nucleotide Polymorphism, Metabolic Phenotype, Exercise Intervention, Dietary Intervention, Lifestyle Intervention, Gene-Lifestyle Interaction, Body Composition, Adult Men
- Medical subject headings
- Obesity, Obesity, Metabolically Benign, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Aerobic and Resistance ExerciseBehavioural
Participants completed a 12-week supervised exercise program conducted 5 days per week.
The aerobic exercise component consisted of 10 sessions per week, approximately 90 minutes per session, performed at 60% to 70% of maximum heart rate. Activities included aerobic exercise classes, boxing-style aerobic exercise, step exercise, cycling, interval-based exercise, and other structured aerobic activities. Heart rate was monitored during training.
The resistance exercise component consisted of 5 sessions per week, approximately 90 minutes per session, performed at approximately 40% to 60% of one-repetition maximum. Exercises included machine-based circuit training, core training, and strength and body-shaping exercises. Training was supervised by qualified instructors.
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | All participants received the same 12-week supervised lifestyle intervention consisting of aerobic exercise, resistance training, and an individualized energy-controlled diet. Participants were subsequently classified according to baseline metabolic phenotype and MC4R rs17782313 genotype for subgroup analyses; these classifications did not determine intervention assignment. Receives: Behavioral: Supervised Aerobic and Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight at Week 12
Body weight was measured in kilograms using a calibrated electronic scale, with participants wearing light clothing and no shoes. Change in body weight was calculated as the body weight measured at Week 12 minus the baseline body weight.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same 12-week combined exercise and dietary intervention. Participants were classified at baseline according to metabolic phenotype and MC4R rs17782313 genotype for subgroup and interaction analyses. Metabolic phenotype and genotype did not determine intervention assignment.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nijia Meng, Harbin Sport University
- Investigators
- Nijia Meng, Principal investigator, Harbin Sport UniversityXichao Zhang, Study director, Harbin Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750197
- Sponsor's protocol ID
- HSU-MC4R-2025-01
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 6 Aug 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of MC4R rs17782313 Polymorphism and Metabolic Phenotype With Responses to a 12-Week Combined Exercise and Dietary Intervention in Adult Men With Obesity
- ClinicalTrials.gov ID
- NCT07750197
- Acronym / sponsor ID
- HSU-MC4R-2025-01
- Keywords
- MC4R, rs17782313, Single Nucleotide Polymorphism, Metabolic Phenotype, Exercise Intervention, Dietary Intervention, Lifestyle Intervention, Gene-Lifestyle Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Harbin Sport UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Aug 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.
This study evaluated whether differences in the MC4R rs17782313 gene variant and metabolic health status were associated with different responses to a 12-week exercise and dietary intervention in adult men with obesity.
A total of 40 men aged 18 to 59 years with obesity participated in the study. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity according to metabolic risk factors. All participants received the same supervised lifestyle intervention, which included aerobic exercise, resistance training, and an individualized energy-controlled diet.
Body weight, body composition, physical fitness, blood pressure, blood glucose, blood lipids, glycated hemoglobin, and fasting insulin were measured before and after the 12-week intervention. Blood samples were also collected for MC4R rs17782313 genotyping. The study examined whether changes after the intervention differed according to baseline metabolic phenotype and MC4R genotype.
Detailed description
This was a completed, single-center lifestyle intervention study involving adult men with obesity in Harbin, China.
Eligible participants were men aged 18 to 59 years with a body mass index of at least 28 kg/m2 and a waist circumference of at least 90 cm. At baseline, participants were classified as having metabolically healthy obesity or metabolically unhealthy obesity using criteria based on the National Cholesterol Education Program Adult Treatment Panel III.
Metabolically unhealthy obesity was defined as obesity accompanied by at least two of the following metabolic abnormalities: elevated blood pressure, elevated fasting blood glucose, elevated triglycerides, or reduced high-density lipoprotein cholesterol. Metabolically healthy obesity was defined as obesity accompanied by no more than one of these abnormalities.
All participants received the same 12-week supervised exercise and dietary intervention. The exercise program was conducted 5 days per week and consisted of aerobic exercise performed at approximately 60% to 70% of maximum heart rate and resistance exercise performed at approximately 40% to 60% of one-repetition maximum.
Daily energy intake was individualized according to standard body weight. The planned macronutrient distribution was approximately 50% to 60% of energy from carbohydrates, 15% to 20% from protein, and 20% to 30% from fat.
Anthropometric and body-composition assessments included body weight, body mass index, fat mass, body fat percentage, muscle mass, waist circumference, hip circumference, and waist-to-hip ratio. Physical fitness assessments included vital capacity, handgrip strength, vertical jump, push-ups, sit-ups, sit-and-reach flexibility, one-leg standing with eyes closed, choice reaction time, and back strength.
Physiological and biochemical assessments included resting heart rate, systolic and diastolic blood pressure, fasting blood glucose, triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, glycated hemoglobin, and fasting insulin. Measurements were conducted at baseline and after 12 weeks.
MC4R rs17782313 genotype and baseline metabolic phenotype were analytical stratification variables. They were not used to assign different interventions. The study evaluated changes from baseline to week 12 and examined whether intervention responses were associated with metabolic phenotype, MC4R genotype, or their interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same 12-week combined exercise and dietary intervention. Participants were classified at baseline according to metabolic phenotype and MC4R rs17782313 genotype for subgroup and interaction analyses. Metabolic phenotype and genotype did not determine intervention assignment.
| Arm | Type | Receives |
|---|---|---|
| Combined Exercise and Dietary Intervention | Experimental | Behavioral: Supervised Aerobic and Resistance ExerciseAll participants received the same 12-week supervised lifestyle intervention consisting of aerobic exercise, resistance training, and an individualized energy-controlled diet. Participants were subsequently classified according to baseline metabolic phenotype and MC4R rs17782313 genotype for subgroup analyses; these classifications did not determine intervention assignment. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male sex
- Age 18 to 59 years
- Body mass index of at least 28 kg/m2
- Waist circumference of at least 90 cm
- Able and willing to provide written informed consent
Key exclusion criteria (8 listed)
- Severe hepatic insufficiency
- Severe renal insufficiency
- Cardiovascular disease
- Other clinically significant vascular disease
- Current use of glucose-lowering medication
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 |
|---|---|---|
| Supervised Aerobic and Resistance ExerciseParticipants completed a 12-week supervised exercise program conducted 5 days per week. The aerobic exercise component consisted of 10 sessions per week, approximately 90 minutes per session, performed at 60% to 70% of maximum heart rate. Activities included aerobic exercise classes, boxing-style aerobic exercise, step exercise, cycling, interval-based exercise, and other structured aerobic activities. Heart rate was monitored during training. The resistance exercise component consisted of 5 sessions per week, approximately 90 minutes per session, performed at approximately 40% to 60% of one-repetition maximum. Exercises included machine-based circuit training, core training, and strength and body-shaping exercises. Training was supervised by qualified instructors. | Behavioural | Combined Exercise and Dietary Intervention |
Primary outcome
Change From Baseline in Body Weight at Week 12
Time frame: Baseline and Week 12
Body weight was measured in kilograms using a calibrated electronic scale, with participants wearing light clothing and no shoes. Change in body weight was calculated as the body weight measured at Week 12 minus the baseline body weight.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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. This study is not recruiting at the moment.
Nijia Meng principal investigator
Harbin Sport University
Xichao Zhang study director
Harbin Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Aerobic and Resistance Exercise in people with Obesity and Metabolically Healthy Obesity, run by Harbin Sport University at 1 site in China.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 6 Aug 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Body Weight at Week 12 (time frame: Baseline and Week 12). 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 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.