Protein Requirements After Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-65
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male aged 18 - 65 years,
Primary RYGB surgery one to ten years before,
Weight stable within 5% over the last 3 months,
Normotensive or blood pressure controlled with antihypertensive therapy,
Disqualifiers
Current diagnosis of cancer or active cancer in the preceding 1 year,
Any chronic or acute disease which is known to affect amino acid absorption, metabolism, or requirements,
Weight loss after bariatric surgery of less than 40% of excess weight,
Weight regain after bariatric surgery greater than 20% of nadir weight,
Trial population
Participants for the study will be recruited among the patients of the Obesity Clinic of the University Hospitals Leuven (UZ Leuven Obesity Clinic) or from individuals recruited through patients-groups.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Male adults with previous RYGB surgery
Trial outcomes
Primary outcomes
1
estimated average protein requirements
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
Time frame
Postprandial 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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov