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

Obesity Clinical Trial

— BIBOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249326
• Other study ID #: CHU-0084
• Secondary ID: 2009-A01093-54
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: March 19, 2015

Study information

• Verified date: November 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 19, 2015
• Est. primary completion date: March 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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: ß-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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Other:
• bariatric surgery
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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (5)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to measure the nitrogen balance and its variation during weight loss		before, after 3 months and 1 year after the operation
Secondary	Protein metabolism of body and muscle will be assessed		before and 3 months after surgery
Secondary	- 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
Secondary	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
Secondary	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
Secondary	Muscle mass will be estimated by urinary creatinine measurements		before, after 3 months and 1 year after the operation).
Secondary	Intestinal flora microbiology analysis will be performed		3 months and 1 year after bariatric surgery
Secondary	Daily physical activity will be measured by an Acti-Heart apparatus		before, after 3 months and 1 year after surgery
Secondary	- Insulino-resistance will be measured by the HOMA test( test aHomeostatic Model Assessment)and the DISSE index ((Disse E, Diabetes & Metabolism, 2008).		before, after 3 months and 1 year after surgery)
Secondary	Inflammatory, hormonal, metabolic parameters' variation will be assessed by blood biological and urinary parameters measurement		before, after 3 months and 1 year after surgery).