Protein Supplementation Intervention on Body Weight

What Was Tested

In this not phased trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

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.

It had four arms (groups): CRD (placebo comparator), CRD+GLP-1RA (active comparator), CRD+GLP-1RA+HP (experimental) and Healthy Comparators (other).

They will receive calorie restricted balanced diet and placebo.

They will receive calorie restricted balanced diet and semaglutide.

The registry classes the interventions as behavioral, dietary supplement and drug.

More on the Plan

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: 1.

CRD: calorie restricted balanced diet; 2.

CRD + GLP-1RA: CRD plus semaglutide; 3.

Who Took Part

Enrollment: 140 planned participants were the target.

It was open to people of any sex aged from 20 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 20 to 50 years. Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m². Overweight or obese participants:. Willingness to participate in this study and provide signed informed consent.

The full record lists 4 inclusion and 27 exclusion criteria; among the exclusions: abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):; waist circumference ≥ 90 cm for men or ≥ 85 cm for women; systolic blood pressure ≥ 130 mmhg or diastolic blood pressure ≥ 85 mmhg, or currently under antihypertensive treatment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2025-06-10 with completion listed for 2026-12-31.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in Body Weight (kg) from Baseline to Week 12 (time frame: Baseline and Week 12).

It also tracked 37 secondary outcomes, for example Change in Energy Expenditure Rate (kcal/minute) from Baseline to Week 12, Change in Respiratory Quotient from Baseline to Week 12, Change in Fat Oxidation Rate (g/minute) from Baseline to Week 12, Change in Carbohydrate Oxidation Rate (g/minute) from Baseline to Week 12, Change in Waist Circumference (cm) from Baseline to Week 12 and Change in Hip Circumference (cm) from Baseline to Week 12.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 140 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.