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

Purpose

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.

Condition	Intervention
Obesity Bariatric Surgery	Other: bariatric surgery

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Protein Need and Interest of " Quick Proteins " to the Obese Subject Operated by Bariatric Surgery (BIBOP)

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

to measure the nitrogen balance and its variation during weight loss [ Time Frame: before, after 3 months and 1 year after the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Protein metabolism of body and muscle will be assessed [ Time Frame: before and 3 months after surgery ] [ Designated as safety issue: Yes ]
- Body composition will be assessed using deuterated water (2H2O) ingested and by BIA (Bioelectrical Impedance Analysis ) [ Time Frame: before, after 3 months and 1 year after surgery ] [ Designated as safety issue: Yes ]
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 [ Time Frame: before and 3 months after surgery ] [ Designated as safety issue: Yes ]
The voluntary muscular force and muscular weariness will be assessed in Clermont-Ferrand and Lyon by Dynatrac measurement apparatus [ Time Frame: before, after 3 months and 1 year after the operation ] [ Designated as safety issue: Yes ]
Muscle mass will be estimated by urinary creatinine measurements [ Time Frame: before, after 3 months and 1 year after the operation). ] [ Designated as safety issue: Yes ]
Intestinal flora microbiology analysis will be performed [ Time Frame: 3 months and 1 year after bariatric surgery ] [ Designated as safety issue: Yes ]
Daily physical activity will be measured by an Acti-Heart apparatus [ Time Frame: before, after 3 months and 1 year after surgery ] [ Designated as safety issue: Yes ]
- Insulino-resistance will be measured by the HOMA test( test aHomeostatic Model Assessment)and the DISSE index ((Disse E, Diabetes & Metabolism, 2008). [ Time Frame: before, after 3 months and 1 year after surgery) ] [ Designated as safety issue: Yes ]
Inflammatory, hormonal, metabolic parameters' variation will be assessed by blood biological and urinary parameters measurement [ Time Frame: before, after 3 months and 1 year after surgery). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	December 2010
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249326

Contacts

Contact: Patrick LACARIN

04 73 75 11 95

placarin@chu-clermontferrand.fr

Locations

France
CHU Clermont-Ferrand	Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Centre de Recherche en Nutrition Humaine d'Auvergne

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Hospices Civils de Lyon

Service de médecine du Sport et des Explorations Fonctionnelles – CHRU de Clermont-Ferrand

Investigators

Principal Investigator:

Yves BOIRIE

University Hospital, Clermont-Ferrand

More Information

No publications provided

Responsible Party:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT01249326 History of Changes
Other Study ID Numbers:	CHU-0084, 2009-A01093-54
Study First Received:	November 15, 2010
Last Updated:	July 13, 2012
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Morbid obesity,
Bariatric surgery, by-pass, sleeve gastrectomy,
Nitrogen balance,

Protein requirement,
Weight loss
Muscle wasting, muscle disability

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013