An interventional study of General lifestyle and nutritional education and Calorie-restricted balanced diet in Obesity, Weight Loss and Protein Supplementation, sponsored by Chinese Academy of Sciences. Recruiting at 1 site in China. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Chinese Academy of Sciences · Not applicable, Interventional, and Prevention
This study is a randomized clinical trail with a parallel design, involving 120 overweight/obese (body-mass index, BMI ≥ 24 kg/m²) participants and 20 normal-weight participants. Overweight/obese participants will be randomly allocated to one of three groups: 1) calorie restricted balanced diet (CRD)group; 2) CRD + semaglutide group; or 3) CRD + segaglutide with protein supplementation. Through a 3-month weight loss intervention and 6-month follow-up, this study aims to investigate the effects of dietary protein supplementation combined with semaglutide on weight loss, energy and glucose and lipid metabolism, muscle loss, and weight regain. Additionally, the study will explore key factors affecting intervention efficacy, including obesity phenotypes, gut microbiota profiles, genetic backgrounds, and lifestyle factors, to provide evidence for optimizing individualized intervention strategies.
The primary objective of this study is to determine whether adding dietary protein supplementation to GLP 1 receptor agonist (GLP-1RA, semaglutide) therapy enhances weight loss efficacy, improves energy and glucose-lipid metabolism, mitigates muscle loss, and prevents weight regain. Investigators will also explore key modifiers of treatment response-including obesity phenotype, gut microbiota composition, genetic background, and lifestyle factors-to provide an evidence base for personalized interventions.
Investigators will enroll 120 adults with overweight or obesity (BMI ≥ 24 kg/m²) and randomly assign them (1 : 1 : 1) to one of three 3 month interventions:
Baseline and post intervention assessments will include questionnaires; evaluations of diet, physical activity, and sleep patterns; physical examination (height, weight, waist and hip circumference, blood pressure, pulse); body composition analysis; hepatic fat and fibrosis imaging; facial skin phenotyping; 14 day continuous glucose monitoring; 14 day accelerometer based sleep and activity monitoring; stool and urine collection; and a mixed-macronutrient tolerance test (MMTT) performed in a metabolic chamber.
During the MMTT, participants consume a standardized beverage containing 126.5 g glucose, 30.67 g fat, and 34.5 g protein. Blood samples are collected at 0, 0.5, 1, 2, 3, 4, and 5 hours to characterize post prandial dynamics of energy metabolism, routine clinical biomarkers, and metabolomic profiles. Throughout the intervention, dietary intake is recorded via a mobile application, and body weight changes are tracked with an application linked smart scale.
Six months after the intervention, participants undergo follow up assessments (identical questionnaires, physical examination, fasting laboratory tests for glucose, insulin, HbA1c, lipids, and liver and renal function indices) and provide a stool sample.
To provide a healthy reference, Investigators will additionally recruit 20 normal weight adults who will receive weight maintenance dietary counseling for 3 months and undergo pre and post intervention MMTTs in the metabolic chamber. These data will help determine whether the metabolic homeostasis of overweight/obese participants after the three interventions approaches that of healthy individuals and will aid in identifying determinants of inter individual variability.
The study protocol has been approved by the Ethics Committee of Zhejiang Provincial Tongde Hospital.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 140 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).
Exclusion Criteria:
Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):
1. Normal weight (18.5 kg/m² ≤ \< 24 kg/m²):
2. Overweight or obese (BMI ≥ 24 kg/m²):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
They will receive calorie restricted balanced diet and placebo
Behavioral: Calorie-restricted balanced diet
They will receive calorie restricted balanced diet and semaglutide
Behavioral: Calorie-restricted balanced diet · Drug: semaglutide
They will receive calorie restricted balanced diet, semaglutide, and 30g/day of dietary protein supplementation
Behavioral: Calorie-restricted balanced diet · Drug: semaglutide · Dietary Supplement: Dietary protein supplementation
They will receive general lifestyle and nutritional education.
Behavioral: General lifestyle and nutritional education
Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.
Participants will receive 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 and APP-connected scale will be used to monitor their weight changes during interventions.
Participants will receive semaglutide as medically prescribed
participants will receive 30 g/day of dietary protein supplementation
Change in Body Weight (kg) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Weight will be assessed using a Seca-255 scale (ScalesGalore).
Time frame: Baseline and Week 12
Change in Energy Expenditure Rate (kcal/minute) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Energy expenditure rate (kcal/minute) will be assessed with a whole-room indirect calorimeter.
Time frame: Baseline and Week 12
Change in Respiratory Quotient from Baseline to Week 12
The change between the baseline and after 12-week intervention. Respiratory quotient will be assessed with a whole-room indirect calorimeter.
Time frame: Baseline and Week 12
Change in Fat Oxidation Rate (g/minute) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Fat oxidation rate (g/minute) will be assessed with a whole-room indirect calorimeter.
Time frame: Baseline and Week 12
Change in Carbohydrate Oxidation Rate (g/minute) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Carbohydrate oxidation rate (g/minute) will be assessed with a whole-room indirect calorimeter.
Time frame: Baseline and Week 12
Change in Waist Circumference (cm) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Waist circumference will be assessed using a Seca-201tape (ScalesGalore).
Time frame: Baseline and Week 12
Change in Hip Circumference (cm) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Hip circumference will be assessed using a Seca-201 tape (ScalesGalore).
Time frame: Baseline and Week 12
Change in Fat-free Mass (kg) From Baseline to Week 12
Absolute change in whole-body fat-free mass measured by dual-energy X-ray absorptiometry (DXA; GE Lunar iDXA). Values at Week 12 will be subtracted from baseline; a positive value indicates an increase in fat-free mass.
Time frame: Baseline (Week 0) and Week 12
Change in Fat Mass (kg) From Baseline to Week 12
Absolute change in whole-body fat mass measured by dual-energy X-ray absorptiometry (DXA; GE Lunar iDXA). Values at Week 12 minus baseline; a positive value indicates an increase in fat mass.
Time frame: Baseline (Week 0) and Week 12
Change in Controlled Attenuation Parameter (CAP, dB/m) from Baseline to Week 12
The change between the baseline and after 12-week intervention. CAP will be assessed using FibroScane (Echosens). The median CAP value of 10 valid measurements will be used (IQR ≤ 30%). Reported value = Week 12 CAP minus baseline CAP; positive values indicate increased hepatic steatosis.
Time frame: Baseline and Week 12
Change in Systolic Blood Pressure (mmHg) from Baseline to Week 12
The change in systolic blood pressure between the baseline and after 12-week intervention. Systolic blood pressure will be assessed with an electronic blood pressure monitor (Omron J750).
Time frame: Baseline and Week 12
Change in Diastolic Blood Pressure (mmHg) from Baseline to Week 12
The change in diastolic blood pressure between the baseline and after 12-week intervention. Diastolic blood pressure will be assessed with an electronic blood pressure monitor (Omron J750).
Time frame: Baseline and Week 12
Change in Heart Rate (beats/minute) from Baseline to Week 12
The change in heart rate between the baseline and after 12-week intervention. Heart rate will be assessed using Omron J750.
Time frame: Baseline and Week 12
Change in Fasting Glucose (mmol/L) from Baseline to Week 12
The change of fasting glucose between the baseline and after 12-week intervention. Glucose will be measured using a hexokinase enzymatic assay.
Time frame: Baseline and Week 12
Change in Glucose Incremental AUC (mmol·min/L) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an oral mixed-meal tolerance test (MMTT). Glucose will be measured using a hexokinase enzymatic assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in HbA1c (%) from Baseline to Week 12
The change between the baseline and after 12-week intervention. HbA1c will be assessed using high-performance liquid chromatography
Time frame: Baseline and Week 12
Change in Fasting Insulin (µIU/mL) from Baseline to Weel 12
The change of fasting insulin between the baseline and after 12-week intervention. Insulin will be measured using an electrochemiluminescence assay.
Time frame: Baseline and Week 12
Change in Insulin Incremental AUC (µIU·min/mL) from Baseline to Weel 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. Insulin will be measured using an electrochemiluminescence assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in Fasting C-peptide (ng/mL) from Baseline to Week 12
The change of fasting C-peptide between the baseline and after 12-week intervention. C-peptide will be measured using an electrochemiluminescence assay.
Time frame: Baseline and Week 12
Change in C-peptide Incremental AUC (ng·min/mL) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. C-peptide will be measured using an electrochemiluminescence assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in Mean 24-h Glucose (mg/dL) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Mean 24-h glucose will be assessed using Continuous Glucose Monitoring (FreeStyle Libre 2, Abbott) for 14 consecutive days.
Time frame: Baseline and Week 12
Change in Glucose Coefficient of Variation (CV, %) from Baseline to Week 12
The change between the baseline and after 12-week intervention. Glucose CV) will be calculated as (SD/mean) × 100 % from continuous glucose monitoring (FreeStyle Libre 2, Abbott). Participants will wear the sensor for 14 consecutive days at each time point.
Time frame: Baseline and Week 12
Change in Fasting Serum Triglycerides (mmol/L) from Baseline to Week 12
The change of fasting serum triglycerides between the baseline and after 12-week intervention. Serum triglycerides will be quantified using an enzymatic colorimetric assay.
Time frame: Baseline and Week 12
Change in Triglyceride Incremental AUC (mmol·min/L) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. Triglyceride will be measured using an enzymatic colorimetric assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in Fasting Serum Total Cholesterol (mmol/L) from Baseline to Week 12
The change of fasting total cholesterol between the baseline and after 12-week lifestyle intervention. Total cholesterol will be quantified in serum using an enzymatic colorimetric assay.
Time frame: Baseline and Week 12
Change in Total Cholesterol Incremental AUC (mmol·min/L) from Baseline at 12 Weeks
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. Total cholesterol will be measured using an enzymatic colorimetric assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C, mmol/L) from Baseline to Week 12
The change of fasting HDL-C between the baseline and after 12-week lifestyle intervention. HDL-C will be quantified in serum using an enzymatic colorimetric assay.
Time frame: Baseline and Week 12
Change in HDL-c Incremental AUC (mmol·min/L) from Baseline to 12 Weeks
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. HDL-c will be measured using an enzymatic colorimetric assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C, mmol/L) from Baseline to Week 12
The change of fasting LDL-C between the baseline and after 12-week lifestyle intervention. LDL-C will be quantified in serum using an enzymatic colorimetric assay.
Time frame: Baseline and Week 12
Change in LDL-c Incremental AUC (mmol·min/L) from Baseline to 12 Weeks
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. LDL-c will be measured using an enzymatic colorimetric assay. Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value. Reported value = Week 12 iAUC - baseline iAUC; positive numbers indicate an increase.
Time frame: Baseline and Week 12
Change in GLP-1 Incremental AUC (pg·min/mL) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. GLP-1 will be quantified using a high-sensitivity ELISA . Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value.
Time frame: Baseline and Week 12
Change in GIP Incremental AUC (pg·min/mL) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. GIP will be quantified using a high-sensitivity ELISA . Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value.
Time frame: Baseline and Week 12
Change in Ghrelin Incremental AUC (pg·min/mL) from Baseline to Week 12
Venous blood will be collected at 0, 30, 60, 120, 180, 240, and 300 min during an MMTT. Ghrelin will be quantified using a high-sensitivity ELISA . Incremental area under the concentration-time curve (iAUC) will be calculated via the trapezoidal rule after subtracting the fasting value.
Time frame: Baseline and Week 12
Change in Shannon Diversity Index From Baseline to Week 12
Fecal DNA will be extracted and subjected to shotgun metagenomic sequencing on an Illumina NovaSeq 6000 (2 × 150 bp; ≥6 Gb per sample). Reads will be taxonomically profiled using MetaPhlAn 4.0. The Shannon diversity index will be calculated for each sample.
Time frame: Baseline and Week 12
Change in Relative Abundance of Akkermansia muciniphila (%) From Baseline to Week 12
Same sequencing workflow as above. Relative abundance (% of total classified reads) of A. muciniphila will be extracted from MetaPhlAn output. Reported value = Week 12 minus baseline abundance.
Time frame: Baseline and Week 12
Single nucleotide polymorphism (SNPs)
Mutations at specific sites will be detected using a genotyping microarray.
Time frame: Baseline
Change in body weight from Week 12 to 6 months post-intervention
The hange from the end of intervention (Week 12) to 6 months post-intervention. Weight will be assessed using Seca-255 scale (ScalesGalore).
Time frame: Post-intervention 6 months
Change in Facial Skin Phenotype from Baseline to Week 12
The change between the baseline and after 12-week lifestyle intervention.Facial skin phenotype will assessed using Meitueve 3D skin analysis system (Meitu, China).
Time frame: Baseline and Week 12
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Chinese Academy of Sciences