NCT07156552

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

Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-06-20
• Primary completion: 2026-09-30
• Completion: 2027-06-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

2 sites across 1 country: Netherlands