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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance exercise training and protein supplementation

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Control group - Standard careNo intervention 0 interventions
Group B: Intervention group - Enriched careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of Fat-free mass loss/Total weight loss >30%

Time frame
From enrollment to 3 months post-surgery

Secondary outcomes

1

Weight (kg)

Time frame
From enrollment to 12 months post-surgery
2

Body Mass Index (kg/m2)

Time frame
From enrollment to 12 months post-surgery
3

Body composition (fat-mass/fat-free mass) (kg)

Time frame
From enrollment to 12 months post-surgery
4

Waist circumference (cm)

Time frame
From enrollment to 12 months post-surgery

Other outcomes

Sponsors and contacts

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Radboud University Medical Center

Lead sponsor

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

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Nederlandse Obesitas Kliniek

Collaborator