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

Primary Purpose

Morbid Obesity

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Hydrolyzed Proteins

Intact proteins

About this trial

This is an interventional prevention trial for Morbid Obesity

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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
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

Sites / Locations

Hôpital AvicenneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrolized proteins

Intact proteins

Arm Description

Group receiving hydrolyzed proteins in the postprandial metabolic test

Group receiving intact proteins in the postprandial metabolic test

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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).

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.

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.

Full Information

NCT ID

NCT04934826

First Posted

February 24, 2021

Last Updated

October 3, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04934826

Brief Title

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

Acronym

RyDIGEST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 7, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydrolized proteins

Arm Type

Experimental

Arm Description

Group receiving hydrolyzed proteins in the postprandial metabolic test

Arm Title

Intact proteins

Arm Type

Active Comparator

Arm Description

Group receiving intact proteins in the postprandial metabolic test

Intervention Type

Dietary Supplement

Intervention Name(s)

Hydrolyzed Proteins

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Intact proteins

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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.

Time Frame

6 months after By-pass

Secondary Outcome Measure Information:

Title

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.

Description

Time Frame

6 months after By-pass

Title

Description

Time Frame

6 months after By-pass

Title

Description

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.

Time Frame

6 months after By-pass

Title

Description

Time Frame

6 months after By-pass

Title

Evaluate post-prandial splanchnic sequestration of dietary amino acids

Description

Time Frame

6 months after By-pass

Title

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

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gheorghe AIRINEI, Doctor

Phone

01 48 95 74 30

gheorghe.airinei@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Zahia BEN ABDESSELAM

Phone

01 48 95 7435

zahia.ben-abdesselam@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gheorghe AIRINEI, Doctor

Organizational Affiliation

Assistance Publique - Hôpitaux Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Avicenne

City

Bobigny

ZIP/Postal Code

93000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

AIRINEI Gheorghe, Dr

gheorghe.airinei@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all IPD that underlie results in a publication

IPD Sharing 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.

IPD Sharing 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.

Citations:

PubMed Identifier

21741734

Citation

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.

Results Reference

background

PubMed Identifier

26891123

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.

Results Reference

background

PubMed Identifier

17311946

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.

Results Reference

background

PubMed Identifier

15640465

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.

Results Reference

background

PubMed Identifier

26290008

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.

Results Reference

background

PubMed Identifier

17093159

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.

Results Reference

background

PubMed Identifier

23576048

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.

Results Reference

background

Links:

URL

https://www.anses.fr/fr/system/files/NUT-Ra-Proteines.pdf

Description

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

Learn more about this trial

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

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