Clinical trial
Protein Requirements After Bariatric Surgery
Recruiting now · Not applicable · 1 countries · Registry ID NCT06853652
Recruiting nowNot applicableObservational
What this study is about
The study investigates protein requirements at least 1 year after gastric bypass surgery in adult males, to investigate whether protein requirements are elevated compared to protein requiremens for the general populaiotn. The main study outcome is the estimated average protein requirements for the study populaiton.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexMale
Healthy volunteersNot accepted
ConditionObesity and Overweight, Bariatric Surgery (Gastric Bypass), Protein Requirement
Full registry 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.
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
estimated average protein requirementsPostprandial plateau in amino acid oxidation, after 8 hours of feeding. 49 studies (7 at 7 protein intake levels each) will be conducted over 6 months to determine to outcome collectively for all participants.
Estimated protien requirements will be calculated for the total study population, not per participant, and expressed as g/kg bodyweight and g/kg fat free mass
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Universitaire Ziekenhuizen KU Leuven🇧🇪 Leuven, Belgium
Gabriel EksteenContact