NCT07658261

Brief Summary

This randomized controlled trial investigated the effects of upper body-based and lower body-based combined training on serum levels of myostatin (MSTN) and hormone-sensitive lipase (HSL) in overweight and obese men. Myostatin is a myokine involved in the regulation of skeletal muscle growth and adipose tissue metabolism, while HSL is a key enzyme involved in lipolysis and fat mobilization. Thirty-six overweight and obese men were assigned to either an upper body combined training group, a lower body combined training group, or a non-exercising control group. The intervention consisted of 10 weeks of combined resistance and aerobic training performed three times per week. Serum levels of MSTN and HSL were measured before and after the intervention to determine whether upper body-focused and lower body-focused combined training produce different effects on markers associated with muscle growth and lipid metabolism.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 14, 2026

Last Update Submit

June 18, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in serum myostatin (MSTN) concentration

    Serum myostatin concentration measured by enzyme-linked immunosorbent assay (ELISA). The outcome was assessed before the intervention and 48 hours after completion of the 10-week training program.

    Baseline and 10 weeks

  • Change in serum hormone-sensitive lipase (HSL) concentration

    Serum hormone-sensitive lipase concentration measured by enzyme-linked immunosorbent assay (ELISA). The outcome was assessed before the intervention and 48 hours after completion of the 10-week training program.

    Baseline and 10 weeks

Study Arms (3)

Upper Body Combined Training

EXPERIMENTAL

Participants completed a 10-week upper body-focused combined training program three times per week. Each session consisted of upper body resistance exercises followed by aerobic exercise performed on a hand ergometer. Resistance training included chest press, rowing machine, biceps curl, triceps extension, shoulder press, and abdominal exercises.

Behavioral: Upper Body Combined Training

Lower Body Combined Training

EXPERIMENTAL

Participants completed a 10-week lower body-focused combined training program three times per week. Each session consisted of lower body resistance exercises followed by aerobic exercise performed on a leg ergometer. Resistance training included leg press, leg extension, leg flexion, leg abduction, leg adduction, and calf raise exercises.

Behavioral: Lower Body Combined Training

Control

NO INTERVENTION

Participants in the control group did not participate in the exercise intervention and were instructed to maintain their usual daily activities throughout the 10-week study period.

Interventions

Participants completed a 10-week upper body-focused combined training program performed three times per week. Each session included six upper body resistance exercises (chest press, rowing machine, biceps curl, triceps extension, shoulder press, and abdominal machine exercises) followed by aerobic exercise on a hand ergometer. Resistance training was performed for 3 sets during the first 5 weeks and 4 sets during weeks 6-10, with 8-12 repetitions per set. Aerobic exercise began at 20 minutes and increased by 1 minute each week, reaching 29 minutes in the final week. Exercise intensity was maintained at approximately 57-66% of maximum heart rate during aerobic training.

Also known as: Upper Body Resistance and Aerobic Training
Upper Body Combined Training

Participants completed a 10-week lower body-focused combined training program performed three times per week. Each session included six lower body resistance exercises (leg press, leg extension, leg flexion, leg abduction, leg adduction, and calf raise exercises) followed by aerobic exercise on a leg ergometer. Resistance training was performed for 3 sets during the first 5 weeks and 4 sets during weeks 6-10, with 8-12 repetitions per set. Aerobic exercise began at 20 minutes and increased by 1 minute each week, reaching 29 minutes in the final week. Exercise intensity was maintained at approximately 57-66% of maximum heart rate during aerobic training.

Also known as: Lower Body Resistance and Aerobic Training
Lower Body Combined Training

Eligibility Criteria

Age20 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male participants aged 20 to 45 years.
  • Body mass index (BMI) ≥25 kg/m².
  • Overweight or obese status.
  • No participation in regular resistance or aerobic exercise during the previous 6 months.
  • Willingness to participate and provide written informed consent.

You may not qualify if:

  • Presence of metabolic diseases, including diabetes mellitus.
  • Presence of cardiovascular or respiratory diseases.
  • Musculoskeletal or joint injuries that could interfere with exercise participation.
  • Use of anti-obesity medications.
  • Use of anabolic steroids, sports supplements, or fat-burning supplements.
  • Regular alcohol consumption or tobacco use.
  • Absence from more than two training sessions during the intervention period.
  • Withdrawal of consent or unwillingness to continue participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports and Health Sciences of the University of Tehran

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was used in this study. Participants, investigators, and study personnel were aware of group assignments due to the nature of the exercise interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of three parallel groups: an upper body combined training group, a lower body combined training group, or a non-exercising control group. Each intervention group completed a 10-week training program consisting of resistance and aerobic exercise performed three times per week, while the control group maintained their usual lifestyle habits.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

May 1, 2024

Primary Completion

May 1, 2024

Study Completion

December 15, 2024

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available. The study was not originally designed with a formal data-sharing plan, and participant-level data contain information that could potentially compromise participant confidentiality.

Locations