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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Dietary Supplement: Hydrolyzed Proteins
* Dietary Supplement: Intact proteins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrolized proteins<br>Group receiving hydrolyzed proteins in the postprandial metabolic test | Dietary Supplement: Hydrolyzed Proteins<br>* Patients in experimental arm will receive a test meal based on marked hydrolyzed proteins<br>|
| Active Comparator: Intact proteins<br>Group receiving intact proteins in the postprandial metabolic test | Dietary Supplement: Intact proteins<br>* Patients in active comparator arm will receive a meal based on intact marked proteins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |