Clinical trial NCT05785221: Lifestyle Intervention on Metabolic Homeostasis
Official title: Exploratory Personalized Lifestyle Intervention on Metabolic Homeostasis in Overweight or Obese Chinese Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Homeostasis
Metabolism and Nutrition Disorder
Healthy
Obesity
Keywords: Metabolic homeostasis
Healthy
Lifestyle intervention
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Sir Run Run Shaw Hospital
First posted: 2023-03-27
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 personalized nutritional and lifestyle weight reduction intervention will be conducted in the overweight or obese participants. The objectives of this study are to 1) characterize metabolic homeostasis under resting and exercise conditions, 2) to explore the potential impact factors on metabolic homeostasis, and 3) to investigate whether personalized nutritional and lifestyle weight reduction intervention can improve metabolic health in overweight or obese Chinese individuals and how is it comparable to healthy normal weight Chinese population.

Detailed description: The objectives of this study are to 1) characterize metabolic homeostasis under resting and exercise conditions, 2) to explore the potential impact factors on metabolic homeostasis, and 3) to investigate whether personalized nutritional and lifestyle weight reduction intervention can improve metabolic health in overweight or obese Chinese individuals and how is it comparable to healthy normal weight Chinese population.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Metabolic Homeostasis Score at 12 Weeks
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in Body Weight at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Mass Index at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Waist Circumference at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Hip Circumference at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Blood Pressure at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Heart Rate at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Body Composition at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Energy Expenditure at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Respiratory Quotient at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Glucose Homeostasis at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Glucose at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in C-peptide at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Insulin Indices at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Lipid Parameters at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Protein and Amino Acids Metabolites at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Inflammatory Biomarkers and Cytokines at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Gastrointestinal Hormones at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Cell Adhesion Molecules at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Adipokines at 12 Weeks
timeFrame: Baseline and Week 12
measure: Change from Baseline in Metabolomics at 12 Weeks
timeFrame: Baseline and Week 12
measure: Single nucleotide polymorphism (SNPs)
timeFrame: Baseline
measure: Gut microbiota 16S rDNA sequencing
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS
name: Xu Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: