Energy Metabolism Profiles Over Weight-loss and Eating Responses (NCT05785221) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Energy Metabolism Profiles Over Weight-loss and Eating Responses
China117 participantsStarted 2023-03-02
Plain-language 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. 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
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 20-70 years of age, inclusive
* BMI ≥ 24kg/m2
* Not in other clinical studies currently or in the past three months
Exclusion Criteria:
* 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
* 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
* Cogni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting and postprandial energy metabolic response at baseline and post-intervention