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ObesityBIBOPNCT01249326

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

A study testing bariatric surgery in people with Obesity and Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Bariatric Surgery
What is being tested?
bariatric surgery
How many people
25 participants
Where
1 siteFrance
Study dates
Dec 2010to 19 Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 26Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

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.

Read the 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 changes, for the mass and muscle function. Three groups of patients will be studied: One group undergoing sleeve gastrectomy in Clermont-Ferrand (group 1: n = 20) will be followed by current recommendations. A second group undergoing sleeve gastrectomy in Clermont-Ferrand (group 2: n = 20) will receive during three months, protein supplement (powder whey protein ("fast")) at dose of 40g / day. 10 patients in group 1 and 10 patients in group 2 will participate in protein metabolism study. The third group undergoing gastric bypass in Lyon (group 3: n = 20) will be followed by the current recommendations and will participate in study of endotoxemia.

Being tested
bariatric surgery
Keywords
Morbid obesity,, Bariatric surgery, by-pass, sleeve gastrectomy,, Nitrogen balance,, Protein requirement,, Weight loss, Muscle wasting, muscle disability
Medical subject headings
Obesity, Obesity, Morbid, Weight Loss, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric surgeryOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to measure the nitrogen balance and its variation during weight loss

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

Secondary outcomes (9)

  1. Protein metabolism of body and muscle will be assessed

    Measured: before and 3 months after surgery

  2. - Body composition will be assessed using deuterated water (2H2O) ingested and by BIA (Bioelectrical Impedance Analysis )

    Measured: before, after 3 months and 1 year after surgery

  3. 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

    Measured: before and 3 months after surgery

  4. The voluntary muscular force and muscular weariness will be assessed in Clermont-Ferrand and Lyon by Dynatrac measurement apparatus

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

  5. Muscle mass will be estimated by urinary creatinine measurements

    Measured: before, after 3 months and 1 year after the operation).

  6. Intestinal flora microbiology analysis will be performed

    Measured: 3 months and 1 year after bariatric surgery

  7. Daily physical activity will be measured by an Acti-Heart apparatus

    Measured: before, after 3 months and 1 year after surgery

  8. - Insulino-resistance will be measured by the HOMA test( test aHomeostatic Model Assessment)and the DISSE index ((Disse E, Diabetes & Metabolism, 2008).

    Measured: before, after 3 months and 1 year after surgery)

  9. Inflammatory, hormonal, metabolic parameters' variation will be assessed by blood biological and urinary parameters measurement

    Measured: before, after 3 months and 1 year after surgery).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completion19 Mar 2015
  4. Study completion19 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01249326
Sponsor's protocol ID
CHU-0084
Other IDs
2009-A01093-54
Acronym
BIBOP
Status last verified
Aug 2026
First submitted
15 Nov 2010
Last updated
5 Aug 2026
Results posted
No

Publications

  • 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.

    PubMed 33183568

Questions about this trial

What is this clinical trial studying?

A study testing bariatric surgery in people with Obesity and Bariatric Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to measure the nitrogen balance and its variation during weight loss (time frame: before, after 3 months and 1 year after the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01249326, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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