Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the … (NCT04934826) | Clinical Trial Compass
UnknownNot Applicable
Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass
France40 participantsStarted 2021-09-07
Plain-language summary
The gastric bypass can reduce the bioavailability of food proteins. The bioavailability of hydrolyzed proteins may be higher than intact proteins. Thus, the use of hydrolyzed proteins could compensate for the decrease in protein bioavailability observed after gastric By-pass in morbidly obese patients.
The effectiveness of a hydrolyzed protein intake may be higher than that of an intact protein intake to improve the status of a By-pass.
The hypothesis would be that the use of hydrolyzed proteins would compensate for the decrease in bioavailability of food proteins caused by gastric By-pass.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. Patients with BMI \> 40 kg/m2 or BMI \> 35 kg/m2 associated with at least one comorbidity(s): hypertension, diabetes, cardiovascular disease, hyperlipidemia, sleep apnea, arthritis,hepatic steatosis.
✓. Candidates for RY gastric By-pass bariatric surgery,
✓. Over 18 and under 60 years of age
✓. For women of childbearing age: effective contraception implemented for at least 3 months.
✓. Failure of other medical cares (medical, nutritional, dietetic and psychotherapeutic treatment) well conducted for 6 to 12 months.
✓. Patient affiliated to a social security system (excluding AME) or entitled to benefits.
✓. Patient who agreed to participate by signing the informed consent of the study
Exclusion criteria
✕. Pregnancy or breastfeeding in progress
✕. Severe psychiatric disorder or other illness that may disrupt the study follow-up or to invalidate the proper understanding of the protocol information and the informed consent
What they're measuring
1
Compare the evolution of the bioavailability of hydrolyzed milk proteins to the intact milk proteins in obese patients who have received a By-pass, using the Nitrogen-15 (15N) labelled test meal method