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

Radboud University Medical Center

Status: Enrolling

Conditions: Fat Free Mass; Bariatric Surgery

Treatments: Behavioral: Resistance exercise training and protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT07156552

NL87367.091.24

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Control group - Standard care

No Intervention group

Intervention group - Enriched care

Experimental group

Treatment:

Behavioral: Resistance exercise training and protein supplementation