Comparing protein absorption in morbidly obese patients after gastric bypass
Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese
This study tests if taking hydrolyzed protein supplements helps morbidly obese patients who had gastric bypass surgery absorb protein better than regular protein supplements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT04934826 on ClinicalTrials.gov |
What this trial studies
This study investigates the absorption of hydrolyzed versus intact proteins in morbidly obese patients who have undergone Roux-en-Y gastric bypass surgery. It aims to determine if hydrolyzed proteins can better compensate for the reduced protein bioavailability that often occurs post-surgery. Participants will receive daily supplementation of either hydrolyzed or intact proteins over a three-month period, with the goal of meeting the recommended protein intake of 60 grams per day. The study will measure the effectiveness of these protein forms in improving nutritional status and addressing potential deficiencies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI over 40 or over 35 with comorbidities, who are candidates for gastric bypass surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance nutritional outcomes for morbidly obese patients after gastric bypass surgery.
How similar studies have performed: While the approach of using hydrolyzed proteins is promising, the effectiveness of protein supplementation in this specific context has not been thoroughly assessed in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Candidates for RY gastric By-pass bariatric surgery, 3. Over 18 and under 60 years of age 4. For women of childbearing age: effective contraception implemented for at least 3 months. 5. Failure of other medical cares (medical, nutritional, dietetic and psychotherapeutic treatment) well conducted for 6 to 12 months. 6. Patient affiliated to a social security system (excluding AME) or entitled to benefits. 7. Patient who agreed to participate by signing the informed consent of the study Exclusion Criteria: 1. Pregnancy or breastfeeding in progress 2. 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 3. Patient's foreseeable inability to participate in a clinical trial 4. Severe and unstable eating disorders 5. Patients with a contraindication to amino acid infusion 6. Dependence on alcohol or psychoactive substances such as drugs 7. Metabolic disease requiring a a low protein diet 8. Known allergy to milk proteins 9. Patient under guardianship or curatorship 10. Patient under the justice protection 11. Participation in another interventional research
Where this trial is running
Bobigny
- Hôpital Avicenne — Bobigny, France (Recruiting)
Study contacts
- Principal investigator: Gheorghe AIRINEI, Doctor — Assistance Publique - Hôpitaux Paris
- Study coordinator: Gheorghe AIRINEI, Doctor
- Email: gheorghe.airinei@aphp.fr
- Phone: 01 48 95 74 30
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.