Status:
COMPLETED
Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Centre de Recherche en Nutrition Humaine d'Auvergne
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Conditions:
Obesity
Bariatric Surgery
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The main objective of the study is to evaluate the protein requirement associated with postoperative weight loss caused by by-pass (shunt which leads to a certain degree of malabsorption) or sleeve ga...
Detailed Description
This is a prospective longitudinal study of the effect of bariatric surgery on protein requirements and protein metabolism, and protein supplementation interest, appropriate to the digestive tract cha...
Eligibility Criteria
Inclusion
- \- Males and females.
- Age between 18 to 60 years.
- Body mass index: BMI\> 40 kg/m2,
- Biological Review considered satisfactory by the investigator based on the topics covered
- Serology HIV ( Human Immunodeficiency Virus )and HCV (Hepatitis C Virus ) negative.
- Subject giving his written informed consent
- Affiliated to National Health Insurance
Exclusion
- Subject under 18 or over 60 years.
- Balance Organic considered abnormal by the investigator.
- Serology HIV or HCV positive.
- Pregnant or lactating.
- For women of childbearing age: β-HCG assay positive and not having reliable contraceptives (oral contraceptive, IUD (Intrauterine Device), implant or hormone patch, abstinence).
- Medical or surgical history (judged by investigator to be incompatible with the study).
- Subject with unstable psychiatric condition
- Blood donation in the two months preceding the study.
- Heavy alcohol consumption (\> 2 to 3 glasses per day depending on sex) or presence of an addiction.
- Tobacco significant (\> 5 cigarettes / day or equivalent in cigars or pipe tobacco).
- Subjects with an allergy or intolerance to dairy products.
- Intense sporting activity (\> 5 hours / week).
- Being in exclusion on the National Volonteers Data file or having perceived more than 4500 Euros in the year for clinical study participation.
- No one under guardianship or not subject to social security.
- Subjects deprived of their liberty by judicial or administrative decision.
- Refusal to sign the information sheet and written consent for participation
- Subject with a cardiovascular or neoplasic evolutive disease
- Subject with a severe infection in the 3 months period before inclusion (assessed by doctor during inclusion consultation)
- Hypercorticism and dysthyroïdism
- Subject with a known neuro-muscular disease
- Subject with a chronic or acute inflammatory disease in the 3 months period before inclusion
- Subject treated by: corticoids, immunosupressor, anabolic agents, growth factor or having stopped treatment for less than 3 months before inclusion.
- Furthermore for subjects having undergone a by-pass at Lyon:
- Subject consuming pre or probiotics many times per day, having an impact on intestinal flora.
- Subject with antibiotics during the 3 months before the beginning of the study.
- Subject with an intolerance to dairy products and refusing to consume dairy prod
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01249326
Start Date
December 1 2010
End Date
March 19 2015
Last Update
November 13 2018
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003