Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.

Obesity Clinical Trial

Official title:

Effect of Prebiotic and Synbiotic Supplementation on Inflammatory Markers, Metabolic Parameters and Nutritional Status After Roux-en-y Gastric Bypass.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158676
• Other study ID #: 96156587
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: April 12, 2017
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2017
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.

Description:

The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2) Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. Blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age greater than 18 years and less than 65 years

• Body mass index (BMI)> 40kg/m2 or> 35kg/m2 with at least one comorbidity

• Failure in the non-pharmacological and pharmacological treatment.

Exclusion Criteria:

• Significant intellectual limitations without adequate family support.

• Uncontrolled psychiatric disorder.

• Alcohol dependence and / or illicit drugs dependence.

• Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants

• Display intolerance prebiotics and / or probiotics and / or symbiotic

• Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Prebiotic
Fructooligosaccharides
• Synbiotic
Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019

Other:
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Brazil	Hospital Universitário Polydoro Ernani de São Thiago	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Fröde TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IL-1 beta concentrations	Will be evaluated IL-1 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Primary	Change in IL-6 concentrations	Will be evaluated IL-6 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Primary	Change in TNF-alpha concentrations	Will be evaluated TNF-alpha plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in nutritional status	Will be assessed anthropometric measures: weight and height (baseline, 30 and 45 days after surgery) for the classification of nutritional status according to BMI	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in risk of inflammatory and nutritional complications	Will be calculated the CRP/albumin ratio, as proposed by Correa et al (2002), using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk.	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)
Secondary	Change in fasting glucose concentrations	Will be assessed the plasma concentrations of fasting glucose in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in fasting insulin concentrations	Will be assessed the plasma concentrations of fasting insulin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in HOMA-IR index	Will be assessed the HOMA-IR index in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in glycated hemoglobin	Will be evaluated glycated hemoglobin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in lipid profile	Will be evaluated lipid profile in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation).	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in plasma monounsaturated fatty acids	Will be assessed the proportion (%) of plasma monounsaturated fatty acids	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in plasma polyunsaturated fatty acids	Will be assessed the proportion (%) of plasma polyunsaturated fatty acids	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).
Secondary	Change in plasma saturated fatty acids	Will be assessed the proportion (%) of plasma saturated fatty acids	Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

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