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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Prebiotic
* Dietary Supplement: Synbiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* Maltodextrin - 11g/day<br>|
| Active Comparator: Prebiotic<br>Fructooligosaccharide | Dietary Supplement: Prebiotic<br>* Fructooligosaccharide - 11g/day<br>|
| Active Comparator: Synbiotic<br>Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 | Dietary Supplement: Synbiotic<br>* Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Inflammation, Nutritional status, Prebiotic, Synbiotic