Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity
NCT02660333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2018-10-02
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.
Conditions
- Morbid Obesity
Interventions
- DIETARY_SUPPLEMENT
-
Placebo
Maltodextrin - 11g/day
- DIETARY_SUPPLEMENT
-
Prebiotic
Fructooligosaccharide - 11g/day
- DIETARY_SUPPLEMENT
-
Synbiotic
Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day
Sponsors & Collaborators
-
Universidade Federal de Santa Catarina
lead OTHER
Principal Investigators
-
Erasmo Trindade, PhD · Federal University of Santa Catarina
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2018-02-28
- Completion
- 2018-04-30
Countries
- Brazil
Study Locations
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