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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Resistance exercise training and protein supplementation
BehavioralThe 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
Trial outcomes
Primary outcomes
Prevalence of Fat-free mass loss/Total weight loss >30%
Secondary outcomes
Weight (kg)
Body Mass Index (kg/m2)
Body composition (fat-mass/fat-free mass) (kg)
Waist circumference (cm)
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