Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery

Summary

The goal of this clinical trial is to investigate the effects of daily protein supplementation and participation in a weekly supervised resistance training program on the prevention of excessive muscle mass loss following bariatric surgery. Patients treated at one of the participating centers will be invited to participate and will be randomly assigned to one of two groups.

Participants in group 1 will receive standard postoperative care as currently provided. Participants in group 2 will also receive standard care, but in addition, they will be asked to consume extra protein daily and take part in a supervised resistance training session once a week.

Previous research has shown that approximately one in five patients undergoing bariatric surgery experiences excessive muscle loss after the surgery. It is known that resistance training and protein intake can help maintain and even improve muscle mass. However, limited research has been conducted on the combined effects of protein supplementation and resistance training in patients after bariatric surgery. Therefore, the aim of this trial is to determine whether participants receiving the additional intervention experience less muscle mass loss compared to those receiving standard care alone.

Conditions

• Bariatric Surgery
• Fat Free Mass

Interventions

BEHAVIORAL

Resistance exercise training and protein supplementation

The intervention consists of two components: 1. Resistance Exercise Training Participants will engage in a 24-week resistance training program. This program includes one supervised session per week supervised by a qualified kinesiologist, complemented by two to three additional unsupervised sessions per week performed at home. 2. Protein Supplementation Participants will receive daily protein supplements for a total duration of 12 weeks. The dosage will be progressively increased: * 20 grams per day during weeks 1-4 * 40 grams per day during weeks 5-8 * 60 grams per day during weeks 9-12 After the 12-week supplementation period, participants will receive additional dietary counseling sessions with a dietitian. These sessions aim to support the maintenance of adequate protein intake through dietary intake.

Sponsors & Collaborators

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Nederlandse Obesitas Kliniek

  collaborator UNKNOWN

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• M. T.E. Hopman, Prof. Dr. · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-20

Primary Completion

2026-09-30

Completion

2027-06-30

Countries

• Netherlands

Study Locations