Health TrialsbyHealthPanel

Protein Supplementation Intervention on Body Weight

ConditionsObesityWeight LossProtein Supplementation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorChinese Academy of Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 20 to 50 years.

Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) < 24 kg/m².

Willingness to participate in this study and provide signed informed consent.

Disqualifiers

Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.

Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.

Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.

Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) < 0.9 mmol/L in men or < 1.0 mmol/L in women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • General lifestyle and nutritional education

    Behavioral

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

  • Calorie-restricted balanced diet

    Behavioral

    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.

  • semaglutide

    Drug

    Participants will receive semaglutide as medically prescribed

  • Dietary protein supplementation

    Dietary supplement

    participants will receive 30 g/day of dietary protein supplementation

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: CRDPlacebo comparator 1 intervention
Group B: CRD+GLP-1RAActive comparator 2 interventions
Group C: CRD+GLP-1RA+HPExperimental treatment 3 interventions
Group D: Healthy ComparatorsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now