CompletedNot Applicable

Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)

France25 participantsStarted 2010-12

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 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 Criteria: * 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 deci…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to measure the nitrogen balance and its variation during weight loss

Timeframe: before, after 3 months and 1 year after the operation

Trial details

NCT IDNCT01249326

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03-19

View on ClinicalTrials.gov More Obesity trials