NCT05785221

Energy Metabolism Profiles Over Weight-loss and Eating Responses

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Chinese Academy of Sciences · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Homeostasis
• Metabolism and Nutrition Disorder
• Healthy
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	General lifestyle and nutritional education	Participants will receive general dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.
BEHAVIORAL	Personalized nutritional and lifestyle weight reduction intervention	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.

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-03-01
• Completion: 2026-12-01
• First posted: 2023-03-27
• Last updated: 2026-02-09

Locations

1 site across 1 country: China