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HomeostasisNCT05785221

Energy Metabolism Profiles Over Weight-loss and Eating Responses

A study testing General lifestyle and nutritional education and Personalized nutritional and lifestyle weight reduction intervention in people with Homeostasis and Metabolism and Nutrition Disorder, run by Chinese Academy of Sciences at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an exploratory controlled before-after study, which involves 112 participants, of whom 28 are with normal weight and 84 are overweight or obese. Twelve weeks of caloric-restriction dietary intervention will be conducted in the overweight or obese participants. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
What is being tested?
General lifestyle and nutritional education and Personalized nutritional and lifestyle weight reduction intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
1 siteChina
Study dates
2 Mar 2023to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 20-70 years of age, inclusive
  • BMI ≥ 24kg/m2
  • Not in other clinical studies currently or in the past three months

Who cannot join

  • Fasting glucose >7.0mmol/L or diagnosed diabetes or taking insulin or other blood glucose-lowering drugs
  • Blood pressure > 160/100 mmHg; diagnosed phase II or III hypertension or cannot decrease SBP under 160mmHg after anti-hypertension drugs
  • Fasting blood TG≥ 5.7 mmol/L or fasting LDL-C≥ 4.9 mmol/L or cannot control TG < 5.7 mmol/L or LDL-C < 4.9 mmol/L after taking lipid lowering drugs
  • Pregnant or lactating
  • Attempting to change body weight in the past 3 months
  • Use of antibiotic in the preceding 3 months for 3-serial days
Show all 21Show fewer
  • Use of estrogen therapy or hormonal drugs in the preceding 6 months
  • Smokers
  • History of alcohol abuse or other substance abuse (Alcohol abuse is defined as regular alcohol consumption > 40 g/day for females or > 80 g/day for males)
  • Severe renal disease or liver disease
  • Severe gastrointestinal diseases
  • Surgical events preceding 1 year (except appendicitis or hernia surgery)
  • Severe cardiovascular or cerebrovascular diseases
  • Implantation of heart stent or any device containing metal material
  • Cancer or receiving radiotherapy and chemotherapy within 5 years
  • Hyperthyroidism or hypothyroidism
  • Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
  • Claustrophobia
  • Physical disability
  • Any mental disorders or current use of antidepressants
  • Cognitive disability

Trial locations and contacts

1 site in 1 country.

China1 site
  • Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences

    Hangzhou, Zhejiang, 310024

Other trials in China

About this study

Official title: Exploratory Personalized Lifestyle Intervention on Metabolic Homeostasis in Overweight or Obese Chinese Population

This is an exploratory controlled before-after study, which involves 112 participants, of whom 28 are with normal weight and 84 are overweight or obese. Twelve weeks of caloric-restriction dietary intervention will be conducted in the overweight or obese participants. Before and after the 12-week intervention, metabolic health will be characterized by metabolic homeostasis, determined via comprehensive measurements of dynamic postprandial metabolic responses to a standardized mixed macronutrient tolerance test (75 g glucose, 60 g fat, 20 g protein) in a whole-room indirect calorimeter. The objectives of this study are

  1. to characterize dynamic metabolic response elicited by acute nutritional and acute exercise challenges,
  2. to elucidate biological mechanisms underlying inter-individual heterogeneity in these responses,
  3. to predict prospective weight loss over the intervention using heterogeneous metabolic responses to acute challenges
Read the detailed description

The objectives of this study are 1) to characterize dynamic metabolic response elicited by acute nutritional and acute exercise challenges, 2) to elucidate biological mechanisms underlying inter-individual heterogeneity in these responses, and 3) to predict prospective weight loss over the intervention using heterogeneous metabolic responses to acute challenges.

In this study, 84 overweight or obese participants (BMI ≥ 24 kg/m2) and 28 normal weight participants (18.5 ≤ BMI<24 kg/m2) will be recruited and receive 12-week caloric-restriction dietary or weight maintenance interventions. Before and after the 12-week interventions, metabolic homeostasis will be used to characterize metabolic health and to be determined using comprehensive measurements of dynamic changes in postprandial metabolic responses (including energy metabolism, multiple clinical biomarkers, metabolomic signatures, gut microbiota, genetic signatures etc.) after standardized mixed macronutrient tolerance test (75 g glucose, 60 g fat and 20 g protein) in whole room indirect calorimeter under both resting and exercise conditions. In addition, data from dietary intake, anthropometric measurements, body composition, psychosocial measures, behavior questionnaires and 14-day continuous glucose monitoring will also be collected to characterize metabolic homeostasis. During the interventions, participants will receive personalized dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians. APP-connected wearable devices will be utilized to monitor their dietary intakes, physical activities and sleep conditions, and an application-connected scale will be used to monitor their weight changes during interventions. The study's protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital.

Being tested
General lifestyle and nutritional education, Personalized nutritional and lifestyle weight reduction intervention
Keywords
Metabolic homeostasis, Healthy, Lifestyle intervention
Medical subject headings
Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General lifestyle and nutritional educationBehavioural

    Participants will receive general dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.

  • Personalized nutritional and lifestyle weight reduction interventionBehavioural

    Participants will receive personalized dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians. APP-connected wearable devices will be utilized to monitor their dietary intakes, physical activities and sleep conditions and APP-connected scale will be used to monitor their weight changes during interventions.

Study groups in NCT05785221
Study groupRoleWhat they receive
Healthy ComparatorsPlacebo comparatorThey will receive general lifestyle and nutritional education.
Receives: Behavioral: General lifestyle and nutritional education
Overweight/Obese GroupExperimentalThey will receive personalized nutritional and lifestyle weight reduction intervention including dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians.
Receives: Behavioral: Personalized nutritional and lifestyle weight reduction intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting and postprandial energy metabolic response at baseline and post-intervention

    Energy metabolism is characterized by four primary indicators: energy expenditure (EE), respiratory quotient (RQ), carbohydrate oxidation rate (CarbOx), and fat oxidation rate (FatOx).

    EE denotes the rate of energy expenditure per minute (typically expressed in kcal/min).

    RQ, defined as the ratio of carbon dioxide produced to oxygen consumed (VCO₂/VO₂), reflects whole-body substrate utilization.

    CarbOx and FatOx represent the respective oxidation rates of carbohydrate and fat, quantifying the contribution of each macronutrient to total energy production.

    Measured: Baseline and Week 12

Secondary outcomes (22)
  1. Change from Baseline in Body Weight at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Weight will be assessed by Seca-255 (ScalesGalore).

    Measured: Baseline and Week 12

  2. Change from Baseline in Body Mass Index at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Weight and height will be assessed by Seca-255 (ScalesGalore).

    Measured: Baseline and Week 12

  3. Change from Baseline in Waist Circumference at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Waist circumference will be assessed by Seca-201(ScalesGalore).

    Measured: Baseline and Week 12

  4. Change from Baseline in Hip Circumference at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Waist circumference will be assessed by Seca-201(ScalesGalore).

    Measured: Baseline and Week 12

  5. Change from Baseline in Blood Pressure at 12 Weeks

    The change of systolic and diastolic blood pressures between the baseline and after 12-week lifestyle intervention. Both systolic pressure and diastolic pressure will be assessed using electronic blood pressure monitor (Omron J750).

    Measured: Baseline and Week 12

  6. Change from Baseline in Heart Rate at 12 Weeks

    The change of systolic and diastolic blood pressures between the baseline and after 12-week lifestyle intervention. Heart rate will be assessed using Omron J750.

    Measured: Baseline and Week 12

  7. Change from Baseline in Body Composition at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Body composition will assessed using dual energy x-ray absorptiometry (DXA) (GE).

    Measured: Baseline and Week 12

  8. Change from Baseline in Energy Expenditure at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Energy expenditure will be assessed using whole room indirect calorimeter.

    Measured: Baseline and Week 12

  9. Change from Baseline in Respiratory Quotient at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Respiratory quotient will be assessed using whole room indirect calorimeter.

    Measured: Baseline and Week 12

  10. Change from Baseline in Glucose Homeostasis at 12 Weeks

    The change between the baseline and after 12-week lifestyle intervention. Glucose homeostasis will be assessed by Continuous Glucose Monitoring (FreeStyle Libre).

    Measured: Baseline and Week 12

  11. Change from Baseline in Glucose at 12 Weeks

    The dynamic change of glucose from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  12. Change from Baseline in C-peptide at 12 Weeks

    The dynamic change of C-peptide from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  13. Change from Baseline in Insulin Indices at 12 Weeks

    The dynamic change of insulin indices from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  14. Change from Baseline in Lipid Parameters at 12 Weeks

    The dynamic change of lipid parameters from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  15. Change from Baseline in Protein and Amino Acids Metabolites at 12 Weeks

    The dynamic change from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  16. Change from Baseline in Inflammatory Biomarkers and Cytokines at 12 Weeks

    The dynamic change from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  17. Change from Baseline in Gastrointestinal Hormones at 12 Weeks

    The dynamic change in gastrointestinal hormones from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  18. Change from Baseline in Cell Adhesion Molecules at 12 Weeks

    The dynamic change in cell adhesion molecules from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  19. Change from Baseline in Adipokines at 12 Weeks

    The dynamic change in adipokines from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention.

    Measured: Baseline and Week 12

  20. Change from Baseline in Metabolomics at 12 Weeks

    The dynamic change in metabolomics including profiling of free fatty acids and other metabolites from 0 to 30, 60, 120, 180, 240, 300 minutes pre- and post-oral mixed-nutrient dietary challenge between the baseline and after 12-week lifestyle intervention. Metabolomics will be measured by LC-MS.

    Measured: Baseline and Week 12

  21. Single nucleotide polymorphism (SNPs)

    Mutations at specific sites will be detected by gene chip.

    Measured: Baseline

  22. Gut microbiota 16S rDNA sequencing

    Gut microbiota 16S rDNA will be sequenced and community composition will be analyzed.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start2 Mar 2023
  3. Primary completion1 Mar 2025
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785221
Sponsor's protocol ID
HIAS-LIMH-202302
Status last verified
Feb 2026
First submitted
1 Mar 2023
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing General lifestyle and nutritional education and Personalized nutritional and lifestyle weight reduction intervention in people with Homeostasis and Metabolism and Nutrition Disorder, run by Chinese Academy of Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting and postprandial energy metabolic response at baseline and post-intervention (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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