Daily protein plus weekly resistance training to prevent muscle loss after 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
The trial will test whether taking a daily protein supplement and doing one supervised resistance workout each week helps people having bariatric surgery keep their muscle mass.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT07156552 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study will compare usual postoperative care to usual care plus daily protein supplementation and one supervised resistance training session per week in patients undergoing Roux-en-Y gastric bypass or sleeve gastrectomy. Participants treated at participating centers will be randomly assigned to the two groups and followed for changes in fat-free mass and related outcomes. The study targets prevention of excessive muscle loss, a complication reported in about 20% of bariatric patients. While resistance training and protein intake are each known to support muscle mass, the combined effect in the bariatric population will be measured.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for Roux-en-Y gastric bypass or sleeve gastrectomy who are enrolled in the Nederlandse Obesitas Kliniek (NOK) care program and able to follow supplement and weekly supervised exercise procedures.
Not a fit: Patients with milk-protein allergy or lactose intolerance, diagnosed renal insufficiency, or intestinal diseases that impair protein absorption — and those unable to attend weekly supervised sessions — may not benefit or may be excluded.
Why it matters
Potential benefit: If successful, the approach could help patients retain muscle mass and strength after bariatric surgery, improving recovery and long-term function.
How similar studies have performed: Previous studies show resistance training and increased protein intake each help preserve or build muscle, but randomized data on the combined intervention specifically after bariatric surgery are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam and 1 other locations
- Nederlandse Obesitas Kliniek — Amsterdam, Netherlands (Not_yet_recruiting)
- Nederlandse Obesitas Kliniek — Nieuwegein, Netherlands (Recruiting)
Study contacts
- Principal investigator: M. T.E. Hopman, Prof. Dr. — Radboud University Medical Center
- Study coordinator: J. H.M. Karregat, Dr.
- Email: jan.karregat@radboudumc.nl
- Phone: +31653461919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.