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 range20 Years – 70 Years
SexALL
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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…
What they're measuring
1
Fasting and postprandial energy metabolic response at baseline and post-intervention