Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity
- Conditions
- Morbid Obesity
- Interventions
- Dietary Supplement: SynbioticDietary Supplement: PrebioticDietary Supplement: Placebo
- Registration Number
- NCT02660333
- Lead Sponsor
- Universidade Federal de Santa Catarina
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Age greater than 18 years and less than 60 years
- Body mass index (BMI)≥40kg/m2
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Synbiotic Synbiotic Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 Prebiotic Prebiotic Fructooligosaccharide Placebo Placebo Maltodextrin
- Primary Outcome Measures
Name Time Method Cytokines 2 months Plasma IL-1, IL-6, IL-8, IL-10, IL-12p70 and TNF-alpha concentrations (pg/mL)
C-reactive protein 2 months Serum C-reactive protein concentrations (mg/L)
- Secondary Outcome Measures
Name Time Method Waist circumference 2 months Waist circumference (cm)
Triglycerides 2 months Serum concentrations of triglycerides (mg/dL)
LDL-c 2 months Serum concentrations of LDL-cholesterol (mg/dL)
Brain-derived neurotrophic factor (BDNF) 2 months Plasma Brain-derived neurotrophic factor (ng or pg/mL)
Body mass index 2 months Body mass index (kg/m²)
Fasting insulin 2 months Serum concentrations of insulin (IU/mL)
Sodium 2 months Serum concentrations of sodium (mEq/L)
Growth hormone 2 months Serum concentrations of Growth hormone (ng/mL)
Iron 2 months Serum concentrations of iron (mg/dL)
HDL-c 2 months Serum concentrations of HDL-cholesterol (mg/dL)
Phosphorus 2 months Serum concentrations of phosphorus(mg/dL)
Folic acid 2 months Serum concentrations of folic acid (ng/mL)
Glycated hemoglobin 2 months Blood concentrations of glycated hemoglobin (%)
Total cholesterol 2 months Serum concentrations of total cholesterol (mg/dL)
Calcium 2 months Serum concentrations of calcium (mg/dL)
Potassium 2 months Serum concentrations of potassium (mEq/L)
Blood glucose 2 months Blood glucose concentrations (mg/dL)
Cortisol 2 months Plasma cortisol (ug/dL)
Adrenocorticotropic Hormone (ACTH) 2 months Plasma Adrenocorticotropic Hormone (pg/mL)
Vitamin B12 2 months Serum concentrations of vitamin B12 (pg/mL)
Vitamin D 2 months Serum concentrations of vitamin D (ng/dL)
Body weight 2 months Body weight (kg)
Ghrelin 2 months Plasma ghrelin (pg/mL)
Hepcidin 2 months Hepcidin (ng/mL)
Leptin 2 months Plasma leptin (ng/mL)
Parathormone (PTH) 2 months Parathormone (ng/mL)
Thyroid-Stimulating Hormone (TSH) 2 months Thyroid-Stimulating Hormone (µIU/mL)
Trial Locations
- Locations (1)
Polydoro Ernani de São Thiago University Hospital
🇧🇷Florianópolis, SC, Brazil