Energy Metabolism Profiles Over Weight-loss and Eating Responses

Chinese Academy of Sciences

Status: Active, not recruiting

Conditions: Healthy; Metabolism and Nutrition Disorder; Obesity; Homeostasis

Treatments: Behavioral: Personalized nutritional and lifestyle weight reduction intervention; Behavioral: General lifestyle and nutritional education

Study type: Interventional

Funder types: Other

Identifiers

NCT05785221

HIAS-LIMH-202302

Details and patient eligibility

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 personalized nutritional and lifestyle weight reduction intervention will be conducted in the overweight or obese participants. The objectives of this study are 1) to characterize energy metabolic responses under acute nutritional challenge and acute exercise challenge, 2) to investigate whether weight-loss intervention can improve metabolic health, and 3) to explore the potential impact factors on heterogenous postprandial and post-intervention energy metabolism.

Full description

The objectives of this study are 1) to characterize energy metabolic responses under acute nutritional challenge and acute exercise challenge, 2) to investigate whether weight-loss intervention can improve metabolic health, and 3) to explore the potential impact factors on heterogenous postprandial and post-intervention energy metabolism.

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 personalized weight reduction or weight maintenance nutritional and lifestyle 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 the standardized mixed-nutrient dietary challenges (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.

Enrollment: 117 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups, including a placebo group

Healthy Comparators

Placebo Comparator group

Description:

They will receive general lifestyle and nutritional education.

Treatment:

Behavioral: General lifestyle and nutritional education

Overweight/Obese Group

Experimental group

Description:

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

Treatment:

Behavioral: Personalized nutritional and lifestyle weight reduction intervention