NCT06923163

Brief Summary

The goal of this clinical trial is to study the effectiveness of aerobic exercise in treating obesity in adults and to assess the efficacy of exercise. The primary research questions it seeks to address are as follows:

  • To what extent does exercise increase the total energy expenditure of participants?
  • Why and how does the energy expenditure from exercise not fully compensate for the total energy expenditure (TEE)?
  • Researchers will assess the efficacy and potential challenges of using exercise as a treatment for obesity by comparing the measurement data before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20). Participants will engage in the following activities:
  • Engage in running sessions supervised five times a week for a duration of 12 weeks.
  • Attend laboratory sessions both before and after the exercise intervention period for metabolic and anthropometric measurements, as well as sample collection.
  • Return to the laboratory for further metabolic and anthropometric measurements and sample collection8 weeks post-completion of exercise intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress39%
May 2025Dec 2027

First Submitted

Initial submission to the registry

April 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

April 3, 2025

Last Update Submit

January 19, 2026

Conditions

Sedentary BehaviorHealthy ParticipantsAdult

Keywords

Metabolic responseEnergy expenditureEnergy compensation

Outcome Measures

Primary Outcomes (5)

  • Change in TEE.

    The change in TEE will be evaluated using the DLW method before and after exercise intervention.

    Three times, it takes 14 days for each time: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in TEF and REE.

    The change in BEE and TEF will be measured through indirect calorimetry in a respiratory chamber.

    Three times, it takes 1 days for each time: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in exercise energy expenditure.

    The change in exercise energy expenditure will be assessed using indirect calorimetry with a respiratory hood system (COSMED).

    Three times, it takes 14 days for each time: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in food intake.

    Food intake will be assessed using a 2-day food record complemented by photographing and weighing the food before and after consumption.

    Three times, food intake assessment takes 2 days: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in physical activity.

    The physical activity levels of the participants will be monitored through the use of a GT3X accelerometer.

    Three times, it takes takes 14 days: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

Secondary Outcomes (6)

  • Change in fasting glucose and postprandial glucose.

    Three times, 7 days per each time: before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in circulating hormones and metabolites.

    8 times, 1 minutes for each collection, 7 days for analysis. Every months (week0, 4, 8,12, and 30), and after exercise energy expenditure test(week 0,12, and 20))

  • Change in intestinal microbiota.

    Three times, it takes 5 minutes for collection, 7 days for analysis. before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in fat mass.

    Three times, it takes 10 minutes, before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • Change in fat free mass.

    Three times, it takes 2 minutes for each time, before exercise intervention (week 0), immediately after exercise intervention (week 12), and 8 weeks post-completion of exercise intervention (week 20).

  • +1 more secondary outcomes

Other Outcomes (2)

  • Change in metabolic energy expenditure before and after an intense exercise session.

    1 day, before and after the first intense exercise session

  • Change in metabolic energy expenditure upon completion of exercise intervention.

    1 day, before and after the last exercise session

Study Arms (1)

Exercise intervention

EXPERIMENTAL

Participants will run on treadmill under the supervision of the researcher * Intensity:60% of VO2max * Duration: for 12 weeks * Frequency: 5 times a week.

Behavioral: Exercise intervention

Interventions

Exercise interventionBEHAVIORAL

Exercise prescription for participant， * 150Kcal for Weeks 1-4 (gradually increase to 150Kcal in the first two weeks as familiar stage), * 250Kcal for Weeks 5-8, * 350Kcal for Weeks 9-12.

Also known as: physical activity
Exercise intervention

Eligibility Criteria

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

You may qualify if:

  • Sedentary individuals
  • BMI ≥ 18.5 kg/m2

You may not qualify if:

  • Individuals who have undergone major surgery in the past 6 months (excluding tooth extraction);
  • Individuals on long-term medication;
  • Individuals with metabolic and cardiovascular diseases such as diabetes, hypoglycemia, and hypertension;
  • Individuals with exercise-related injuries, including joint diseases and fractures;
  • Individuals diagnosed with infectious diseases such as HIV, tuberculosis, malaria, etc.;
  • Individuals with mental and neurological disorders including anorexia nervosa;
  • Individuals who have attempted weight loss or gain through various methods in the past three months;
  • Individuals in preconception, pregnancy, and lactation periods;
  • Individuals with autism and those with metal implants in their bodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Shenzhen, Guangdong, China

RECRUITING

Related Publications (3)

  • 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: 26832439RESULT

  • 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: 34453886RESULT

  • 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: 33665639RESULT

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John R Speakman, PhD

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John R Speakman, PhD

CONTACT

+8615810868669j.speakman@abdn.ac.uk

Xinyi BI, PhD

CONTACT

+8614774821721xy.bi@siat.ac.cn

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

April 3, 2025

First Posted

April 11, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

CN(1)