The Effect of Exercise on Metabolic Alteration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorShenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sedentary individuals
BMI ≥ 18.5 kg/m2
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Exercise intervention
BehavioralExercise 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Exercise interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in TEE.
The change in TEE will be evaluated using the DLW method before and after exercise intervention.
Time frame
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).2
Change in TEF and REE.
The change in BEE and TEF will be measured through indirect calorimetry in a respiratory chamber.
Time frame
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).3
Change in exercise energy expenditure.
The change in exercise energy expenditure will be assessed using indirect calorimetry with a respiratory hood system (COSMED).
Time frame
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).4
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.
Time frame
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).Secondary outcomes
1
Change in fasting glucose and postprandial glucose.
The continuous glucose monitoring system (Medtronic) will record the glucose concentration in mmol/L for 7 days.
Time frame
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).2
Change in circulating hormones and metabolites.
During the experiment, the nurse will collect the fasting blood sample in each month throughout exercise intervention, right after the first and last exercise session, and the 8 weeks upon completion of exercise intervention. Metabolomics will analyze the impact of an exercise intervention on metabolites.
Time frame
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))3
Change in intestinal microbiota.
Feces will be collected for gut microbiome analysis of intestinal microbiota.
Time frame
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).4
Change in fat mass.
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ).
Time frame
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).Other outcomes
1
Change in metabolic energy expenditure before and after an intense exercise session.
Participants will enter the chamber at night to equilibrate the chamber air and become familiar with the setup. The initial light exposure day in the respiratory chamber, labeled as day 0, will not involve any exercise. The subsequent 24 hours will mark the beginning of the exercise intervention, designated as day 1. The alterations of BEE and TEF will be assessed using indirect calorimetry within the respiratory chamber between day 0 and day 1.
Time frame
1 day, before and after the first intense exercise session2
Change in metabolic energy expenditure upon completion of exercise intervention.
Participants will enter the chamber at the second last exercise intervention night to equilibrate the chamber air and become familiar with the setup. The initial light exposure day in the respiratory chamber, labeled as day 84, will be the last day of exercise intervention. The subsequent 24 hours will mark the first day of the completion of exercise intervention, designated as day 85. The alterations of BEE and TEF will be assessed using indirect calorimetry within the respiratory chamber between day 84 and day 85.
Time frame
1 day, before and after the last exercise sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov