Exercise and Diet Responses in Adult Men With Obesity by MC4R Genotype and Metabolic Health

NCT07750197 | Completed

• 1 other identifier: HSU-MC4R-2025-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Metabolically Healthy Obesity; Metabolically Unhealthy Obesity

Keywords

MC4R; rs17782313; Single Nucleotide Polymorphism; Metabolic Phenotype; Exercise Intervention; Dietary Intervention; Lifestyle Intervention; Gene-Lifestyle Interaction; Body Composition; Adult Men

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Study Arms (1)

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.

Behavioral: Supervised Aerobic and Resistance Exercise

Interventions

Supervised Aerobic and Resistance Exercise BEHAVIORAL

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.

Combined Exercise and Dietary Intervention

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbin Sport University: lead

Study Sites (1)

Harbin Sport University

Harbin, Heilongjiang, China

Location

MeSH Terms

Conditions

Obesity; Obesity, Metabolically Benign; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Nijia Meng

  Harbin Sport University

  PRINCIPAL INVESTIGATOR

• Xichao Zhang

  Harbin Sport University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

CN (1)