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

Universidade Federal de Santa Catarina

Status: Completed

Conditions: Morbid Obesity

Treatments: Dietary Supplement: Prebiotic; Dietary Supplement: Placebo; Dietary Supplement: Synbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02660333

UFSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo

Prebiotic

Active Comparator group

Description:

Fructooligosaccharide

Treatment:

Dietary Supplement: Prebiotic

Synbiotic

Active Comparator group

Description:

Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019

Treatment:

Dietary Supplement: Synbiotic