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LEAN-PREPLean Mass Preservation with Exercise and Protein in Obesity on Semaglutide/Tirzepatide

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What is being tested

Resistance exercise

+ Protein Intake

+ Resistance exercise + protein intake

BehavioralDietary SupplementCombination Product
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorDasman Diabetes Institute
Study ContactDr Ebaa Al OzairiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 10, 2025

Actual date on which the first participant was enrolled.

This study investigates whether combining resistance exercises and increased protein intake can help preserve lean body mass and enhance physical function in individuals with obesity who are starting weight loss treatments with semaglutide or tirzepatide. These medications are known to promote weight loss, but there is interest in understanding if additional interventions can prevent the loss of muscle mass and improve overall health outcomes. The study is important as it aims to find ways to maintain muscle strength and improve life quality during the weight loss process, addressing challenges faced by people with obesity. Participants in the study will begin their therapy with semaglutide or tirzepatide, initially taking a low dose which will gradually be increased. They will be randomly placed into one of four groups: a control group, a group focusing on increased protein intake, a group engaging in muscle strengthening exercises, or a group doing both exercises and increasing protein intake. The study will run for six months, assessing the impact of these interventions on muscle mass, physical function, as well as potential benefits on blood sugar levels, cholesterol, liver health, quality of life, physical activity, and sleep. This design aims to provide insights into the best strategies for supporting weight loss while maintaining health.

Official TitleLEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide and Tirzepatide Therapy (LEAN-PREP Study)
NCT06885736
Principal SponsorDasman Diabetes Institute
Study ContactDr Ebaa Al OzairiMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

232 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

2 inclusion criteria required to participate
Age >/= 18 years

BMI 27-45

23 exclusion criteria prevent from participating
Currently or in the past 6 months participating in any vigorous aerobic activity (>1h per week) or any resistance exercise.

BP of 160/100mmHg or higher

Insulin therapy

Any known medical condition that prevents participants from exercising safely

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants assigned to the resistance exercise group will be asked to perform exercises 3 times a week for the intervention period. The first 3 sessions of the exercise will be performed under the supervision of a qualified exercise specialist to ensure that the participants are happy with the exercises and are performing them appropriately. These will also be group sessions to encourage participants to build social connections to support them during the intervention. A similar group social session will take place at week 4 and then every 4 weeks of the study to overcome any issues with the exercises and to ensure progression to an appropriate intensity.

Group II

Experimental
The aim of this arm of the intervention is to ensure a protein intake of 1.6g/kg/day, as this was the intake level identified as the level after which no further effect was found on muscle mass in the meta-regression from (Morton et al., 2018). For the initial 2 weeks of the study, we will ask participants to consume 2 protein drinks, containing 25g protein (3g leucine), per day - one in the morning and one in the evening. At this stage, we won't know the magnitude of reduction of protein intake following initiation of semaglutide/tirzepatide treatment. After 2 weeks, when the first assessment of dietary intake after beginning semaglutide/tirzepatide treatment occurs, the additional protein will be based on the amount required to ensure 1.6g/kg/day with an aim to spread protein evenly across the day and aim for at least 25g protein (3g leucine) per meal or snack.

Group III

Experimental
Participants in this arm will follow the above resistance exercise and protein intake interventions.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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