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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660333
• Other study ID #: UFSC
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2018
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• Placebo
Maltodextrin - 11g/day
• Prebiotic
Fructooligosaccharide - 11g/day
• Synbiotic
Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day

Locations

Country	Name	City	State
Brazil	Polydoro Ernani de São Thiago University Hospital	Florianópolis	SC

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein	Serum C-reactive protein concentrations (mg/L)	2 months
Primary	Cytokines	Plasma IL-1, IL-6, IL-8, IL-10, IL-12p70 and TNF-alpha concentrations (pg/mL)	2 months
Secondary	Triglycerides	Serum concentrations of triglycerides (mg/dL)	2 months
Secondary	Total cholesterol	Serum concentrations of total cholesterol (mg/dL)	2 months
Secondary	LDL-c	Serum concentrations of LDL-cholesterol (mg/dL)	2 months
Secondary	HDL-c	Serum concentrations of HDL-cholesterol (mg/dL)	2 months
Secondary	Blood glucose	Blood glucose concentrations (mg/dL)	2 months
Secondary	Glycated hemoglobin	Blood concentrations of glycated hemoglobin (%)	2 months
Secondary	Growth hormone	Serum concentrations of Growth hormone (ng/mL)	2 months
Secondary	Fasting insulin	Serum concentrations of insulin (IU/mL)	2 months
Secondary	Calcium	Serum concentrations of calcium (mg/dL)	2 months
Secondary	Iron	Serum concentrations of iron (mg/dL)	2 months
Secondary	Sodium	Serum concentrations of sodium (mEq/L)	2 months
Secondary	Potassium	Serum concentrations of potassium (mEq/L)	2 months
Secondary	Phosphorus	Serum concentrations of phosphorus(mg/dL)	2 months
Secondary	Folic acid	Serum concentrations of folic acid (ng/mL)	2 months
Secondary	Vitamin B12	Serum concentrations of vitamin B12 (pg/mL)	2 months
Secondary	Vitamin D	Serum concentrations of vitamin D (ng/dL)	2 months
Secondary	Body weight	Body weight (kg)	2 months
Secondary	Waist circumference	Waist circumference (cm)	2 months
Secondary	Body mass index	Body mass index (kg/m²)	2 months
Secondary	Brain-derived neurotrophic factor (BDNF)	Plasma Brain-derived neurotrophic factor (ng or pg/mL)	2 months
Secondary	Cortisol	Plasma cortisol (ug/dL)	2 months
Secondary	Leptin	Plasma leptin (ng/mL)	2 months
Secondary	Ghrelin	Plasma ghrelin (pg/mL)	2 months
Secondary	Adrenocorticotropic Hormone (ACTH)	Plasma Adrenocorticotropic Hormone (pg/mL)	2 months
Secondary	Hepcidin	Hepcidin (ng/mL)	2 months
Secondary	Parathormone (PTH)	Parathormone (ng/mL)	2 months
Secondary	Thyroid-Stimulating Hormone (TSH)	Thyroid-Stimulating Hormone (µIU/mL)	2 months