Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)
BIBOP
2 other identifiers
interventional
25
1 country
1
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 gastrectomy (more technically conservative with less malabsorption), through the study of nitrogen balance. The benefit of protein supply easily absorbed and with high essential amino acids content (proteins "fast" soluble milk) on protein metabolism and muscle function will also be studied. Endotoxemia and intestinal flora variations were measured before and after bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Dec 2010
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 29, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2015
CompletedNovember 13, 2018
November 1, 2018
4.3 years
November 15, 2010
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to measure the nitrogen balance and its variation during weight loss
before, after 3 months and 1 year after the operation
Secondary Outcomes (9)
Protein metabolism of body and muscle will be assessed
before and 3 months after surgery
- Body composition will be assessed using deuterated water (2H2O) ingested and by BIA (Bioelectrical Impedance Analysis )
before, after 3 months and 1 year after surgery
Changes of endotoxemia will be assessed by measuring blood levels of endotoxin, their carriers, inflammatory cytokines, and protein transfer fasting and after a high fat breakfast test
before and 3 months after surgery
The voluntary muscular force and muscular weariness will be assessed in Clermont-Ferrand and Lyon by Dynatrac measurement apparatus
before, after 3 months and 1 year after the operation
Muscle mass will be estimated by urinary creatinine measurements
before, after 3 months and 1 year after the operation).
- +4 more secondary outcomes
Interventions
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 changes, for the mass and muscle function
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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).
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Centre de Recherche en Nutrition Humaine d'Auvergnecollaborator
- Centre de Recherche en Nutrition Humaine Rhone-Alpecollaborator
- Hospices Civils de Lyoncollaborator
- Service de médecine du Sport et des Explorations Fonctionnelles - CHRU de Clermont-Ferrandcollaborator
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
Guillet C, Masgrau A, Mishellany-Dutour A, Blot A, Caille A, Lyon N, Pereira B, Slim K, Robert M, Disse E, Feugier N, Le Ruyet P, Louvet C, Miolanne M, Farigon N, Laville M, Boirie Y. Bariatric surgery affects obesity-related protein requirements. Clin Nutr ESPEN. 2020 Dec;40:392-400. doi: 10.1016/j.clnesp.2020.06.007. Epub 2020 Oct 1.
PMID: 33183568DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yves BOIRIE
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 29, 2010
Study Start
December 1, 2010
Primary Completion
March 19, 2015
Study Completion
March 19, 2015
Last Updated
November 13, 2018
Record last verified: 2018-11