Protein Supplementation and Resistance Training to Prevent Fat-Free Mass Loss Following Metabolic-Bariatric Surgery
ENRICHED
Effectiveness of Protein SupplementatIon Combined With Resistance Exercise Training to Counteract Disproportional Fat-Free Mass Loss Following Metabolic-Bariatric Surgery: The ENRICHED Study
1 other identifier
interventional
400
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2025
CompletedFirst Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
September 5, 2025
June 1, 2025
1.3 years
July 22, 2025
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of Fat-free mass loss/Total weight loss >30%
From enrollment to 3 months post-surgery
Secondary Outcomes (16)
Weight (kg)
From enrollment to 12 months post-surgery
Body Mass Index (kg/m2)
From enrollment to 12 months post-surgery
Body composition (fat-mass/fat-free mass) (kg)
From enrollment to 12 months post-surgery
Waist circumference (cm)
From enrollment to 12 months post-surgery
Blood pressure (mmHg)
From enrollment to 12 months post-surgery
- +11 more secondary outcomes
Study Arms (2)
Control group - Standard care
NO INTERVENTIONIntervention group - Enriched care
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nederlandse Obesitas Kliniek
Amsterdam, 1043 DS, Netherlands
Nederlandse Obesitas Kliniek
Nieuwegein, 3431, Netherlands
Related Publications (1)
de Roos BM, Yeh LY, van den Hooff PS, Nuijten MAH, Twisk JWR, Liem RSL, van Acker GJD, Severens JL, Kambic T, Serlie MJM, Monpellier VM, Eijsvogels TMH, Hopman MTE, Karregat JHM. Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial. BMJ Open. 2025 Dec 29;15(12):e108346. doi: 10.1136/bmjopen-2025-108346.
PMID: 41469063DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
M. T.E. Hopman, Prof. Dr.
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
September 5, 2025
Study Start
June 20, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
September 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share