Clinical trial NCT02660333: Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Inflammation
Nutritional status
Prebiotic
Synbiotic
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: C-reactive protein
timeFrame: 2 months
measure: Cytokines
timeFrame: 2 months
Secondary outcomes:
measure: Triglycerides
timeFrame: 2 months
measure: Total cholesterol
timeFrame: 2 months
measure: LDL-c
timeFrame: 2 months
measure: HDL-c
timeFrame: 2 months
measure: Blood glucose
timeFrame: 2 months
measure: Glycated hemoglobin
timeFrame: 2 months
measure: Growth hormone
timeFrame: 2 months
measure: Fasting insulin
timeFrame: 2 months
measure: Calcium
timeFrame: 2 months
measure: Iron
timeFrame: 2 months
measure: Sodium
timeFrame: 2 months
measure: Potassium
timeFrame: 2 months
measure: Phosphorus
timeFrame: 2 months
measure: Folic acid
timeFrame: 2 months
measure: Vitamin B12
timeFrame: 2 months
measure: Vitamin D
timeFrame: 2 months
measure: Body weight
timeFrame: 2 months
measure: Waist circumference
timeFrame: 2 months
measure: Body mass index
timeFrame: 2 months
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: 2 months
measure: Cortisol
timeFrame: 2 months
measure: Leptin
timeFrame: 2 months
measure: Ghrelin
timeFrame: 2 months
measure: Adrenocorticotropic Hormone (ACTH)
timeFrame: 2 months
measure: Hepcidin
timeFrame: 2 months
measure: Parathormone (PTH)
timeFrame: 2 months
measure: Thyroid-Stimulating Hormone (TSH)
timeFrame: 2 months
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Polydoro Ernani de São Thiago University Hospital
state: SC
Study officials:
affiliation: Federal University of Santa Catarina
name: Erasmo Trindade, PhD
role: STUDY_DIRECTOR
References: