Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity

Effect of Prebiotic or Synbiotic Supplementation on Inflammatory Response and Indicators of Nutritional Status in Individuals With Morbid Obesity: A Randomized Clinical Trial, Placebo-controlled and Triple Blind

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic) or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Prebiotic; Dietary supplement: Synbiotic

Detailed Description

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Adult individuals of both sexes with morbid obesity (body mass index ≥ 40 kg/m²) will be invited to participate in this randomized, placebo-controlled, triple-blind study. The participants will be divided into three groups: G1 - control group (placebo), G2 - prebiotic group and G3 - synbiotic group. The study will consist of four experimental time points: M0 - baseline and start of supplementation; M1 - after fifteen days of the first outpatient visit and fifteen days after the start of supplementation with prebiotic, synbiotic or placebo; M2 - after thirty days from the first outpatient visit and end of supplementation with prebiotic, synbiotic and placebo; and M3 - time after sixty days from the first outpatient visit. At all time points the inflammatory response will be assessed by determination of plasma cytokines (IL-1, IL-6, IL-10, TNF) and acute phase proteins (c-reactive protein and albumin), besides the evaluation of laboratory and anthropometric indicators of nutritional status. The primary endpoint will be the reduction in concentrations of inflammatory markers (cytokines and acute phase proteins).

Investigators expect to contribute with new information in this field of knowledge, which may facilitate the clinical application of these results.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SC
    • Florianópolis, SC, Brazil, 88040900
      • Polydoro Ernani de São Thiago University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than 18 years and less than 60 years
• Body mass index (BMI)≥40kg/m2

Exclusion Criteria:

• Previous gastrointestinal diseases (e.g. cancer and inflammatory bowel disease)
• Intolerances and/or food allergies (e.g. lactose intolerance and celiac disease)
• Current use of anti-inflammatory drugs and/or antibiotics and/or immunosuppressants
• Regular use of laxatives and/or appetite suppressants
• Current or previous use (up to one month) of prebiotics, probiotics, synbiotics or products enriched with these food compounds
• Intolerance to prebiotic and/or probiotic and/or synbiotic
• Following a diet for weight loss in the last three months
• Pregnant or breastfeeding
• Following unusual diets (e.g. vegetarian, macrobiotic)
• Alcohol dependence and/or illicit drugs dependence
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Maltodextrin	Dietary supplement: Placebo; Maltodextrin - 11g/day
Active Comparator: Prebiotic; Fructooligosaccharide	Dietary supplement: Prebiotic; Fructooligosaccharide - 11g/day
Active Comparator: Synbiotic; Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019	Dietary supplement: Synbiotic; Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	Serum C-reactive protein concentrations (mg/L)	2 months
Cytokines	Plasma IL-1, IL-6, IL-8, IL-10, IL-12p70 and TNF-alpha concentrations (pg/mL)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Serum concentrations of triglycerides (mg/dL)	2 months
Total cholesterol	Serum concentrations of total cholesterol (mg/dL)	2 months
LDL-c	Serum concentrations of LDL-cholesterol (mg/dL)	2 months
HDL-c	Serum concentrations of HDL-cholesterol (mg/dL)	2 months
Blood glucose	Blood glucose concentrations (mg/dL)	2 months
Glycated hemoglobin	Blood concentrations of glycated hemoglobin (%)	2 months
Growth hormone	Serum concentrations of Growth hormone (ng/mL)	2 months
Fasting insulin	Serum concentrations of insulin (IU/mL)	2 months
Calcium	Serum concentrations of calcium (mg/dL)	2 months
Iron	Serum concentrations of iron (mg/dL)	2 months
Sodium	Serum concentrations of sodium (mEq/L)	2 months
Potassium	Serum concentrations of potassium (mEq/L)	2 months
Phosphorus	Serum concentrations of phosphorus(mg/dL)	2 months
Folic acid	Serum concentrations of folic acid (ng/mL)	2 months
Vitamin B12	Serum concentrations of vitamin B12 (pg/mL)	2 months
Vitamin D	Serum concentrations of vitamin D (ng/dL)	2 months
Body weight	Body weight (kg)	2 months
Waist circumference	Waist circumference (cm)	2 months
Body mass index	Body mass index (kg/m²)	2 months
Brain-derived neurotrophic factor (BDNF)	Plasma Brain-derived neurotrophic factor (ng or pg/mL)	2 months
Cortisol	Plasma cortisol (ug/dL)	2 months
Leptin	Plasma leptin (ng/mL)	2 months
Ghrelin	Plasma ghrelin (pg/mL)	2 months
Adrenocorticotropic Hormone (ACTH)	Plasma Adrenocorticotropic Hormone (pg/mL)	2 months
Hepcidin	Hepcidin (ng/mL)	2 months
Parathormone (PTH)	Parathormone (ng/mL)	2 months
Thyroid-Stimulating Hormone (TSH)	Thyroid-Stimulating Hormone (µIU/mL)	2 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Investigators: Study Director: Erasmo Trindade, PhD, Federal University of Santa Catarina

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 29, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Obesity; Prebiotic; Nutritional status; Synbiotic
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: UFSC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED