Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass

NCT04934826 | Unknown

• 2 other identifiers: D201801312019-A01448-49
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (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

  The evolution of bioavailability will be evaluated by the delta of post-prandial bioavailability of food proteins (hydrolysed vs intact) before and 6 months after By-pass.

  6 months after By-pass

Secondary Outcomes (6)

• Evaluate the effect of daily milk protein supplementation administered for 3 months after a post-surgery recovery period of 3 months on protein status in obese patients who had a By-pass.

  6 months after By-pass

• Evaluate the compliance with supplementation of an intact milk protein administered for 3 months after a post-surgery recovery period of 3 months, in obese patients who had a By-pass, as well as its contribution to daily protein intake.

  6 months after By-pass

• Evaluate the compliance with supplementation of an intact milk protein administered for 3 months, after a post-surgery recovery period of 3 months, on spontaneous food consumption in obese patients who had a By-pass.

  6 months after By-pass

• Evaluate the effect of an intact milk protein supplementation administered for 3 months after a post-surgery recovery period of 3 months, on the quality of life in obese patients who have undergone a By-pass surgery.

  6 months after By-pass

• Evaluate post-prandial splanchnic sequestration of dietary amino acids

  6 months after By-pass

Study Arms (2)

Hydrolized proteins

EXPERIMENTAL

Group receiving hydrolyzed proteins in the postprandial metabolic test

Dietary Supplement: Hydrolyzed Proteins

Intact proteins

ACTIVE COMPARATOR

Group receiving intact proteins in the postprandial metabolic test

Dietary Supplement: Intact proteins

Interventions

Hydrolyzed Proteins DIETARY_SUPPLEMENT

Patients in experimental arm will receive a test meal based on marked hydrolyzed proteins

Hydrolized proteins

Intact proteins DIETARY_SUPPLEMENT

Patients in active comparator arm will receive a meal based on intact marked proteins.

Intact proteins

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient's foreseeable inability to participate in a clinical trial
• Severe and unstable eating disorders
• Patients with a contraindication to amino acid infusion
• Dependence on alcohol or psychoactive substances such as drugs
• Metabolic disease requiring a a low protein diet
• Known allergy to milk proteins
• Patient under guardianship or curatorship
• Patient under the justice protection
• Participation in another interventional research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 21741734 BACKGROUND

• 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.

  PMID: 26891123 BACKGROUND

• 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.

  PMID: 17311946 BACKGROUND

• 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.

  PMID: 15640465 BACKGROUND

• 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.

  PMID: 26290008 BACKGROUND

• 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.

  PMID: 17093159 BACKGROUND

• 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.

  PMID: 23576048 BACKGROUND

Related Links

• Guide written by French Food Safety Agency about "Protein intake: consumption, quality, needs and recommendations"

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gheorghe AIRINEI, Doctor

  Assistance Publique - Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gheorghe AIRINEI, Doctor

CONTACT

01 48 95 74 30; gheorghe.airinei@aphp.fr

Zahia BEN ABDESSELAM

CONTACT

01 48 95 7435; zahia.ben-abdesselam@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: June 22, 2021
• Study Start: September 7, 2021
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The final report of the research will be drawn up and signed by the sponsor and the investigator. A summary of the report drawn up according to the reference plan of the competent authority will be sent to the competent authority within one year so it will be sent on february, 2025, after the end of the research, corresponding to the end of the participation of the last person who is willing.
• Access Criteria: The access criteria IPD and any additional supporting information will be shared in the final report or publication. The analysis will be carried out on a modified intention-to-treat basis: all included patients, randomized and whose evaluation at 6 months after surgery will be available, will participate in the analysis in the group assigned by the random draw. This analysis avoids taking into account the patients who will be lost to follow-up before the evaluation at 6 months after the intervention. A per-protocol analysis will also be carried out. Changes in study weight, body composition, blood markers and food intake will be compared between groups using a mixed repeated measures model, with group as a fixed effect and time as the intra-repeat factor. topic. The group's effect on quality of life scores will be analyzed using a Wilcoxon test.

Locations

FR (1)