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Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention

NCT07893249 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-10-25
Last updated
2026-10-23

Condition(s) studied

Physical InactivityOverweightObesity

Investigational drug(s) / intervention(s)

Supervised Aerobic Exercise Programme

Supervised Aerobic Exercise Programme: Participants will perform supervised treadmill exercise five days per week for 12 weeks. Each session will be conducted at 60% of the participant's measured maximal oxygen uptake. The prescribed exercise energy expenditure will be 150 kcal per session in Weeks 1-4, 250 kcal per session in Weeks 5-8, and 350 kcal per session in Weeks 9-12. Session duration will be adjusted individually to meet the energy-expenditure target. Maximal oxygen uptake will be reassessed at prespecified intervals, provisionally at baseline and Weeks 4, 8, and 12, to maintain the prescribed relative intensity. Attendance, completed exercise dose, heart rate, adverse symptoms, and protocol deviations will be documented. 150 Kcal for Weeks 1-4 (gradually increase to 150 Kcal in the first two weeks as familiar stage), 250 Kcal for Weeks 5-8, 350 Kcal for Weeks 9-12.

Study summary

This prospective, single-arm interventional study will investigate why adults receiving the same prescribed dose and relative intensity of exercise show divergent changes in energy balance, body weight, and body composition. A total of 150 sedentary Chinese adults aged 18-40 years with overweight or obesity will complete a 12-week, supervised treadmill exercise programme. Exercise will be performed five times per week at an intensity corresponding to 60% of each participant's measured maximal oxygen uptake. Prescribed exercise energy expenditure will increase progressively from 150 kcal per session in Weeks 1-4 to 250 kcal per session in Weeks 5-8 and 350 kcal per session in Weeks 9-12.

The primary objective is to quantify inter-individual variability in energy compensation after the standardized intervention. Detailed measurements will characterize total and resting energy expenditure, energy intake, appetite, physical activity, body composition, glucose dynamics, cardiorespiratory fitness, brain responses to food-related stimuli, and molecular phenotypes. Multi-omics analyses will include gut microbiome, metabolomic, proteomic, extracellular-vesicle, peripheral blood mononuclear cell, and transcriptomic assessments. The study will explore physiological, behavioral, and molecular factors associated with divergent compensatory responses. No randomized comparator group is included; therefore, causal comparisons between exercise and non-exercise conditions are outside the study scope.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Sedentary individuals * BMI ≥ 24 kg/m2 * Chinese male and female adults * Normal electrocardiogram (ECG) Exclusion Criteria: * Individuals who have undergone major surgery within the past 6 months (tooth extraction excluded); * Individuals with cardiovascular diseases (e.g., hypertension) and severe * metabolic diseases requiring continuous medication (e.g., diabetes); * Exercise-induced injuries, including joint diseases, fractures, etc.; * Individuals with infectious diseases, such as HIV/AIDS, tuberculosis, malaria, etc.; * Psychiatric and neurological disorders, such as anorexia nervosa, etc.; * Individuals who have attempted weight loss or weight gain through various means within the past three months; * Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period * Individuals with claustrophobia or metallic implants in the body which are incompatible with MRI measurements * Individuals who have used antibiotics, probiotics, oral laxatives, etc., within eight weeks; * Individuals with a history of hemophobia or needle phobia. * Individuals who have been drinking deuterium depleted water which is incompatible with the DLW measures.

Primary outcome measure(s)

  • Energy compensation after the 12-week supervised exercise intervention — Baseline to Week 12
    Exercise energy compensation (ExEC), expressed in percentage, will be calculated as \[(ExEE plus change in body energy stores) divided by ExEE\] multiplied by 100. ExEE will be calculated from completed supervised exercise sessions. Change in body energy stores will be derived from changes in fat mass and fat-free mass between baseline and Week 12 and divided by the intervention duration. A value of 0% indicates no compensation, whereas 100% indicates complete compensation for the exercise-induced energy expenditure.

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences Shenzhen Guangdong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07893249 on ClinicalTrials.gov ↗ ← All trials in China