Clinical trial

Energy Metabolism Profiles Over Weight-loss and Eating Responses

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05785221

Active, not recruitingNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 70 Years
SexAll
Healthy volunteersAccepted
ConditionHomeostasis, Metabolism and Nutrition Disorder, Healthy, Obesity

Full registry criteria

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 * Cognitive disability

Treatments and study arms

General lifestyle and nutritional education

Behavioral

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

Personalized nutritional and lifestyle weight reduction intervention

Behavioral

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.

Primary outcomes

Fasting and postprandial energy metabolic response at baseline and post-interventionBaseline and Week 12

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences🇨🇳 Hangzhou, Zhejiang, China