Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass
NCT ID: NCT04934826
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2021-09-07
2025-07-31
Brief Summary
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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.
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Detailed Description
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To overcome this protein undernutrition, protein supplements can be proposed. However, their effectiveness has not been satisfactorily assessed in this situation to date. Indeed, the protein malabsorption potentially induced by the By-pass limits its impact. The value of protein supplementation must also be considered in terms of overall efficacy, taking into account a possible decrease in spontaneous intake related to supplementation.
For the bioavailability studies, milk proteins will be presented in two different forms of the same origin: intact or hydrolyzed proteins. The proteins of the test meal are marked with 15N nitrogen.
For the three months daily supplementation period, the supplements will be intact proteins not marked with 15N nitrogen, provided to patients in the form of individual sachets. The purpose of this supplementation is to help the patient achieve the protein recommendations, which is 60 g/d.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Hydrolized proteins
Group receiving hydrolyzed proteins in the postprandial metabolic test
Hydrolyzed Proteins
Patients in experimental arm will receive a test meal based on marked hydrolyzed proteins
Intact proteins
Group receiving intact proteins in the postprandial metabolic test
Intact proteins
Patients in active comparator arm will receive a meal based on intact marked proteins.
Interventions
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Hydrolyzed Proteins
Patients in experimental arm will receive a test meal based on marked hydrolyzed proteins
Intact proteins
Patients in active comparator arm will receive a meal based on intact marked proteins.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
59 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Gheorghe AIRINEI, Doctor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux Paris
Locations
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Hôpital Avicenne
Bobigny, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Airinei G, Gaudichon C, Bos C, Bon C, Kapel N, Bejou B, Raynaud JJ, Luengo C, Aparicio T, Levy P, Tome D, Benamouzig R. Postprandial protein metabolism but not a fecal test reveals protein malabsorption in patients with pancreatic exocrine insufficiency. Clin Nutr. 2011 Dec;30(6):831-7. doi: 10.1016/j.clnu.2011.06.006. Epub 2011 Jul 8.
Aron-Wisnewsky J, Verger EO, Bounaix C, Dao MC, Oppert JM, Bouillot JL, Chevallier JM, Clement K. Nutritional and Protein Deficiencies in the Short Term following Both Gastric Bypass and Gastric Banding. PLoS One. 2016 Feb 18;11(2):e0149588. doi: 10.1371/journal.pone.0149588. eCollection 2016.
Bos C, Airinei G, Mariotti F, Benamouzig R, Berot S, Evrard J, Fenart E, Tome D, Gaudichon C. The poor digestibility of rapeseed protein is balanced by its very high metabolic utilization in humans. J Nutr. 2007 Mar;137(3):594-600. doi: 10.1093/jn/137.3.594.
Bos C, Juillet B, Fouillet H, Turlan L, Dare S, Luengo C, N'tounda R, Benamouzig R, Gausseres N, Tome D, Gaudichon C. Postprandial metabolic utilization of wheat protein in humans. Am J Clin Nutr. 2005 Jan;81(1):87-94. doi: 10.1093/ajcn/81.1.87.
Oberli M, Marsset-Baglieri A, Airinei G, Sante-Lhoutellier V, Khodorova N, Remond D, Foucault-Simonin A, Piedcoq J, Tome D, Fromentin G, Benamouzig R, Gaudichon C. High True Ileal Digestibility but Not Postprandial Utilization of Nitrogen from Bovine Meat Protein in Humans Is Moderately Decreased by High-Temperature, Long-Duration Cooking. J Nutr. 2015 Oct;145(10):2221-8. doi: 10.3945/jn.115.216838. Epub 2015 Aug 19.
Lacroix M, Bos C, Leonil J, Airinei G, Luengo C, Dare S, Benamouzig R, Fouillet H, Fauquant J, Tome D, Gaudichon C. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino acid requirement. Am J Clin Nutr. 2006 Nov;84(5):1070-9. doi: 10.1093/ajcn/84.5.1070.
Boutrou R, Gaudichon C, Dupont D, Jardin J, Airinei G, Marsset-Baglieri A, Benamouzig R, Tome D, Leonil J. Sequential release of milk protein-derived bioactive peptides in the jejunum in healthy humans. Am J Clin Nutr. 2013 Jun;97(6):1314-23. doi: 10.3945/ajcn.112.055202. Epub 2013 Apr 10.
Related Links
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Guide written by French Food Safety Agency about "Protein intake: consumption, quality, needs and recommendations"
Other Identifiers
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2019-A01448-49
Identifier Type: REGISTRY
Identifier Source: secondary_id
D20180131
Identifier Type: -
Identifier Source: org_study_id
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