Investigating protein needs after gastric bypass surgery
Official title: Maintenance-phase PROtein Requirements After RouX-en-Y-gastric Bypass Surgery
Run by Universitaire Ziekenhuizen KU Leuven · NCT06853652 · Data updated 2026-11-12
This study tests how much protein adult men need after having gastric bypass surgery to see if their needs are different from those of the general population.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Men only |
| Enrollment | 20 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | June 25, 2026 |
| Study ends | June 25, 2026 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06853652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult males aged 18 to 65 who have had Roux-en-Y gastric bypass surgery between one to ten years ago and have maintained stable weight.
✕Probably not a fit
Patients with active cancer, significant weight regain, or chronic diseases affecting amino acid metabolism may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the protein requirements of adult males who have undergone Roux-en-Y gastric bypass surgery at least one year prior. Using the Indicator Amino Acid Oxidation (IAAO) method, the research aims to determine if these protein needs are higher compared to those of the general population. Participants will undergo a series of tests to measure protein oxidation at varying intake levels, allowing researchers to calculate the average protein requirements for this specific group. The findings could provide valuable insights into dietary recommendations for post-bariatric surgery patients.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary guidelines for protein intake in men after gastric bypass surgery.
How similar studies have gone: While there is limited data on this specific approach, studies on protein requirements post-bariatric surgery have shown varying results, indicating a need for further investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male aged 18 - 65 years, 2. Primary RYGB surgery one to ten years before, 3. Weight stable within 5% over the last 3 months, 4. Normotensive or blood pressure controlled with antihypertensive therapy, 5. Provision of informed consent to participate, Exclusion Criteria: 1. Current diagnosis of cancer or active cancer in the preceding 1 year, 2. Any chronic or acute disease which is known to affect amino acid absorption, metabolism, or requirements, 3. Weight loss after bariatric surgery of less than 40% of excess weight, 4. Weight regain after bariatric surgery greater than 20% of nadir weight, 5. Diabetes mellitus defined as a fasting plasma glucose concentration ≥ 7.0 mmol, or HbA1c less than 6.5%, or medical treatment for diabetes.
Where it's running
-
Universitaire Ziekenhuizen KU Leuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Bart Van der Schueren, MD PhD — KU Leuven
- Study coordinator: Gabriel Eksteen, MSc
- Email: gabrieljohannes.eksteen@kuleuven.be
- Phone: +32 16345708
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.