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Completed

NCT Number: NCT02158676

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Polydoro Ernani de São Thiago

Florianópolis, Santa Catarina, 88040-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotic

Dietary Supplement

Fructooligosaccharides

Synbiotic

Dietary Supplement

Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019

Placebo

Other

Maltodextrin

Primary outcomes

  1. Change in IL-1 beta concentrations

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  2. Change in IL-6 concentrations

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  3. Change in TNF-alpha concentrations

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

Secondary outcomes

  1. Change in nutritional status

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    Will be assessed anthropometric measures: weight and height (baseline, 30 and 45 days after surgery) for the classification of nutritional status according to BMI

  2. Change in risk of inflammatory and nutritional complications

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation)

    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.

  3. Change in fasting glucose concentrations

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  4. Change in fasting insulin concentrations

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  5. Change in HOMA-IR index

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  6. Change in glycated hemoglobin

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  7. Change in lipid profile

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    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).

  8. Change in plasma monounsaturated fatty acids

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    Will be assessed the proportion (%) of plasma monounsaturated fatty acids

  9. Change in plasma polyunsaturated fatty acids

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    Will be assessed the proportion (%) of plasma polyunsaturated fatty acids

  10. Change in plasma saturated fatty acids

    Time frame: Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation).

    Will be assessed the proportion (%) of plasma saturated fatty acids

Sponsors and collaborators

Lead sponsor

Universidade Federal de Santa Catarina

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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