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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bariatric Surgery Fat Free Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group - Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group - Enriched care

Group Type EXPERIMENTAL

Resistance exercise training and protein supplementation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A scheduled metabolic-bariatric surgery (i.e. RYGB or Sleeve Gastrectomy)
* Participation in the NOK care program
* Able to understand and perform the study procedures

Exclusion Criteria

* Allergic or sensitive for milk proteins, or lactose intolerant
* Diagnosed renal insufficiency
* Diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No