NCT07893249

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
51mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 25, 2026

Expected
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

3.2 years

First QC Date

September 25, 2026

Last Update Submit

October 21, 2026

Conditions

Keywords

ExerciseEnergy CompensationIndividual Variability

Outcome Measures

Primary Outcomes (1)

  • Energy compensation after the 12-week supervised exercise intervention

    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.

    Baseline to Week 12

Secondary Outcomes (39)

  • Change in body weight

    Weekly from baseline through Week 12, with a follow-up assessment at Week 24 (12 weeks after completion of the intervention).

  • Change in body composition

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • Change in energy expenditure

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • Change in ad libitum energy intake

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • Change in hunger rating

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • +34 more secondary outcomes

Other Outcomes (7)

  • Change in gut microbiome

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • Change in metabolomics

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • Change in circulating proteomic profiles

    Baseline, Week 12, and Week 24 (12 weeks after completion of the intervention).

  • +4 more other outcomes

Study Arms (1)

Supervised Structured Aerobic Exercise

EXPERIMENTAL

All enrolled participants will receive the same progressive, 12-week supervised treadmill exercise programme. The relative exercise intensity will be standardized at 60% of measured maximal oxygen uptake, Actual intensity will be also tested during the first interventional session of each month, while session duration will be individualized to achieve the prescribed energy expenditure.

Behavioral: Supervised Aerobic Exercise Programme

Interventions

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.

Also known as: Exercise training; treadmill exercise; aerobic training
Supervised Structured Aerobic Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary individuals
  • BMI ≥ 24 kg/m2
  • Chinese male and female adults
  • Normal electrocardiogram (ECG)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Shenzhen, Guangdong, China

Location

Related Publications (5)

  • Yegian AK, Pachus E, Redman LM, Heymsfield SB, Falkenhain K, Harris AR, Chacko SK, Wong WW, Lieberman DE. Longitudinal and cross-sectional evidence that daily resting and activity energy expenditures are independent in humans. J Physiol. 2026 Jul;604(14):5952-5967. doi: 10.1113/JP291108. Epub 2026 Jun 25.

    PMID: 42349903BACKGROUND
  • Pontzer H, Durazo-Arvizu R, Dugas LR, Plange-Rhule J, Bovet P, Forrester TE, Lambert EV, Cooper RS, Schoeller DA, Luke A. Constrained Total Energy Expenditure and Metabolic Adaptation to Physical Activity in Adult Humans. Curr Biol. 2016 Feb 8;26(3):410-7. doi: 10.1016/j.cub.2015.12.046. Epub 2016 Jan 28.

    PMID: 26832439BACKGROUND
  • Careau V, Halsey LG, Pontzer H, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Das SK, Cooper R, Dugas LR, Eaton SD, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reilly JJ, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Luke AH, Rood J, Sagayama H, Schoeller DA, Wong WW, Yamada Y, Speakman JR; IAEA DLW database group. Energy compensation and adiposity in humans. Curr Biol. 2021 Oct 25;31(20):4659-4666.e2. doi: 10.1016/j.cub.2021.08.016. Epub 2021 Aug 27.

    PMID: 34453886BACKGROUND
  • Speakman JR, Yamada Y, Sagayama H, Berman ESF, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Creasy SA, Das SK, Cooper R, Dugas LR, Ebbeling CB, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Ludwig DS, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Melanson EL, Luke AH, Pontzer H, Rood J, Schoeller DA, Westerterp KR, Wong WW; IAEA DLW database group. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med. 2021 Feb 16;2(2):100203. doi: 10.1016/j.xcrm.2021.100203. eCollection 2021 Feb 16.

    PMID: 33665639BACKGROUND
  • Pontzer H, Trexler ET. The evidence for constrained total energy expenditure in humans and other animals. Curr Biol. 2026 Feb 23;36(4):1013-1025.e4. doi: 10.1016/j.cub.2026.01.025. Epub 2026 Feb 6.

MeSH Terms

Conditions

Sedentary BehaviorOverweightObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John R Speakman

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 23, 2026

Study Start (Estimated)

October 25, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

October 23, 2026

Record last verified: 2026-10

Locations