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

Morbid Obesity Clinical Trial

— RyDIGEST  

Official title:

Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934826
• Other study ID #: D20180131
• Secondary ID: 2019-A01448-49
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Gheorghe AIRINEI, Doctor
• Phone: 01 48 95 74 30
• Email: gheorghe.airinei[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Surgery is beneficial in terms of weight loss, correction of comorbidities and life expectancy but adverse effects can occur among which various nutritional deficiencies. Thus, in some cases, more or less marked protein undernutrition may be observed.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The effect of an intact milk protein supplementation, administered between 3 months and 6 months after the By-pass, will be evaluated by the variation of albuminemia measured by DEXA and by impedancemetry before 3 months and 6 months after By-pass.; he effect of an intact milk protein supplementation, administered between 3 months and 6 months after the By-pass, will be evaluated by the variation of pre-albuminemia measured by DEXA and by impedancemetry before 3 months and 6 months after By-pass.; he effect of an intact milk protein supplementation, administered between 3 months and 6 months after the By-pass, will be evaluated by the variation of lean mass measured by DEXA and by impedancemetry before 3 months and 6 months after By-pass.	6 months after By-pass
Secondary	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.	The compliance of an intact milk protein supplementation, administered between 3 months and 6 months after the By-pass, will be evaluated by the variation in food intake and protein intake, determined in a food survey	6 months after By-pass
Secondary	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.	The compliance of an intact milk protein supplementation, administered between 3 months and 6 months after the By-pass, will be evaluated by the variation in food intake and protein intake.	6 months after By-pass
Secondary	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.	The effect of administered an intact protein supplementation between 3 months and 6 months after the By-pass on quality of life will be assessed using the Obesity Weight Loss Quality of Life (OWLQOL).	6 months after By-pass
Secondary	Evaluate post-prandial splanchnic sequestration of dietary amino acids	The transfer of 15N nitrogen is evaluated after determination of the enrichment by isotope ratio mass spectrometry (IRMS), the main endpoint is the rate of transfer of 15N nitrogen into the metabolic pools: plasma proteins, plasma urea and urine. In addition, the 15N and 13C isotopic ratios will be determined in the individual blood amino acids by mass spectrometry coupled with gas and combustion chromatography (GC-c-IRMS), in order to determine the digestive bioavailability of the amino acids of the proteins of the test meal.	6 months after By-pass
Secondary	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	he effect of administered an intact protein supplementation between 3 months and 6 months after the By-pass on quality of life will be assessed using the Weight-Related Symptom Measure (WRSM) questionnary.	6 month

External Links

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