NCT02660333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

January 14, 2016

Last Update Submit

September 29, 2018

Conditions

Morbid Obesity

Keywords

ObesityInflammationNutritional statusPrebioticSynbiotic

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (27)

  • Triglycerides

    2 months

  • Total cholesterol

    2 months

  • LDL-c

    2 months

  • HDL-c

    2 months

  • Blood glucose

    2 months

  • +22 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Prebiotic

ACTIVE COMPARATOR

Fructooligosaccharide

Dietary Supplement: Prebiotic

Synbiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Synbiotic

Interventions

PlaceboDIETARY_SUPPLEMENT

Maltodextrin - 11g/day

Placebo
PrebioticDIETARY_SUPPLEMENT

Fructooligosaccharide - 11g/day

Prebiotic
SynbioticDIETARY_SUPPLEMENT

Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day

Synbiotic

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age greater than 18 years and less than 60 years
  • Body mass index (BMI)≥40kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polydoro Ernani de São Thiago University Hospital

Florianópolis, Santa Catarina, 88040900, Brazil

Location

MeSH Terms

Conditions

Obesity, MorbidObesityInflammation

Interventions

PrebioticsSynbiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and BeveragesProbiotics

Study Officials

  • Erasmo Trindade, PhD

    Federal University of Santa Catarina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study participants and researchers were masked over consumption and distribution of supplementation, respectively. Laboratory technicians who performed the blood collection were also masked as to the distribution of supplementation. Supplements and placebo were pre-packaged by the supplier in opaque and closed sachets with randomization codes, being identical in physical appearance, taste and color. Supplement identification codes were only disclosed by the supplier after statistical analysis of study data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 21, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

April 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

BR(1)