LEAN Mass Preservation With Resistance Exercise and Protein During Semaglutide/Tirzepatide Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2029-12-31

Brief Summary

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The aim of the current study is to determine whether resistance exercise and/or protein intake can preserve lean mass and improve physical function in patients with obesity initiating semaglutide/tirzepatide therapy. To achieve this aim the study will have the following objectives.

In people with obesity initiating semaglutide/tirzepatide therapy

1. Form a PPI group to refine the study protocol and establish study materials,
2. Quantify the effects of a pragmatic resistance exercise intervention and/or increasing protein intake on lean mass and physical function during semaglutide/tirzepatide induced weight loss,
3. Establish whether the resistance exercise intervention and/or increasing protein intake has concomitant benefits on glycaemic control, lipids, liver function, quality of life, physical activity and sleep during semaglutide/tirzepatide induced weight loss.

The participants will:

Begin their weight loss medication, starting at a low dose and then increasing the dose to maximize weight loss. They will be randomly assigned by a computer to ONE of the following groups and will be followed up to 6-months:

* Control group
* Protein intake group
* Muscle strengthening exercise group
* Muscle strengthening exercise AND protein intake group.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a 6-month 4 arm (control, resistance exercise, protein intake and resistance exercise + protein intake) randomised controlled trial in people with obesity upon initiation of semaglutide/tirzepatide therapy.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

The researcher and the participant will be blinded to the allocation pattern. It is not possible to blind participants to treatment allocation but people making outcome measurements and performing statistical analysis will be blinded.

Study Groups

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Resistance exercise

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 Type EXPERIMENTAL

Resistance exercise

Intervention Type BEHAVIORAL

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.

Protein Intake

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 Type EXPERIMENTAL

Protein Intake

Intervention Type DIETARY_SUPPLEMENT

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.

Resistance exercise + protein intake

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

Group Type EXPERIMENTAL

Protein Intake

Intervention Type DIETARY_SUPPLEMENT

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.

Resistance exercise + protein intake

Intervention Type COMBINATION_PRODUCT

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

Control

Participants assigned to the control group will be asked to maintain their usual exercise habits

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Resistance exercise

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.

Intervention Type BEHAVIORAL

Protein Intake

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.

Intervention Type DIETARY_SUPPLEMENT

Resistance exercise + protein intake

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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leucine

Eligibility Criteria

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Inclusion Criteria

* Age \>/= 18 years
* BMI 27-45

Exclusion Criteria

* 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
* A personal or family history of medullary thyroid carcinoma
* Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* History of chronic or acute pancreatitis
* History of proliferative diabetic retinopathy or diabetic maculopathy
* History of ketoacidosis or hyperosmolar state/coma
* History of severe hypoglycaemia and/or hypoglycaemia unawareness within last 6 onths
* Clinically significant gastric emptying abnormality or have undergone or plan to undergo gastric bypass or restrictive bariatric surgery or chronically taking drugs that directly affect GI motility
* Any of the following CV conditions in last 2 months: acute MI, stroke or hospitilisation due to CHF
* History of NYHA IV CHF
* Acute or chronic hepatitits, signs and symptoms of any liver disease other than NAFLD, ALT \> 3 times the upper limit of normal
* eGFR \<45mL/min/1.73m2
* Significant uncontrolled endocrine abnormaility in the opinion of clinical investigator
* Serum calcitonin \>35ng/L
* Evidence of active autoimmune abnormality that is likely to requite systemic glucocorticoid treatment in the next 12 months
* Had or waiting for an organ transplant
* History of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years
* Any other aspect of history or condition that may limit the ability of the patient to complete the study
* Having been treated with prescription drugs that promote weight loss in the last 3 months
* Receiving chronic systemic glucocorticoid therapy within last month

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No