Energy Metabolism Profiles Over Weight-loss and Eating Responses

NCT05785221 | Active Not Recruiting

• 1 other identifier: HIAS-LIMH-202302
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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

Conditions

Homeostasis; Metabolism and Nutrition Disorder; Healthy; Obesity

Keywords

Metabolic homeostasis; Healthy; Lifestyle intervention

Outcome Measures

Primary Outcomes (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.

  Baseline and Week 12

Secondary Outcomes (22)

• Change from Baseline in Body Weight at 12 Weeks

  Baseline and Week 12

• Change from Baseline in Body Mass Index at 12 Weeks

  Baseline and Week 12

• Change from Baseline in Waist Circumference at 12 Weeks

  Baseline and Week 12

• Change from Baseline in Hip Circumference at 12 Weeks

  Baseline and Week 12

• Change from Baseline in Blood Pressure at 12 Weeks

  Baseline and Week 12

Study Arms (2)

Healthy Comparators

PLACEBO COMPARATOR

They will receive general lifestyle and nutritional education.

Behavioral: General lifestyle and nutritional education

Overweight/Obese Group

EXPERIMENTAL

They will receive personalized nutritional and lifestyle weight reduction intervention including dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians.

Behavioral: Personalized nutritional and lifestyle weight reduction intervention

Interventions

General lifestyle and nutritional education BEHAVIORAL

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

Healthy Comparators

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.

Overweight/Obese Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: collaborator
• Chinese Academy of Sciences: lead

Study Sites (1)

Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310024, China

Location

MeSH Terms

Conditions

Nutrition Disorders; Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xu Lin, PhD

  Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 27, 2023
• Study Start: March 2, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CN (1)