NCT02505854

Brief Summary

The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

July 16, 2015

Last Update Submit

December 5, 2019

Conditions

Obesity

Keywords

ObesityProbioticSymbioticWeight lossGut microbiotaBifidobacterium lactisFructooligosaccharideBlood sugarLipemiaMetabolome

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of probiotic and symbiotic on weight loss of women obese

    Determine and evaluate change in body weight and body mass index after intervention.

    Baseline and 60 days and 15 days after the end of the intervention

Secondary Outcomes (8)

  • Effect of probiotic and symbiotic on blood glucose

    Baseline, 60 days and 15 days after the end of the intervention

  • Effect of probiotic and symbiotic on insulin resistance

    Baseline and 60 days

  • Effect of probiotic and symbiotic on lipid profile

    Baseline and 60 days

  • Effect probiotic and symbiotic on blood pressure

    Baseline,60 days and 15 days after intervention conclusion

  • Effect of probiotic and symbiotic on gut microbiota composition

    Baseline, 60 days and 15 days after intervention conclusion

  • +3 more secondary outcomes

Study Arms (3)

Probiotic

ACTIVE COMPARATOR

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin

Dietary Supplement: Probiotic

Symbiotic

ACTIVE COMPARATOR

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide

Dietary Supplement: Symbiotic

Placebo

PLACEBO COMPARATOR

Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin

Also known as: Bifidobacterium lactis
Probiotic
SymbioticDIETARY_SUPPLEMENT

Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide

Also known as: Bifidobacterium lactis and fructooligosaccharide
Symbiotic
PlaceboDIETARY_SUPPLEMENT

Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin

Also known as: Gelatin
Placebo

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women;
  • Adult;
  • Obese (BMI between 30 and 39,9 Kg/m²).

You may not qualify if:

  • Pregnancy or nursing;
  • Smokers;
  • Drinkers;
  • Use of drug or phytotherapic;
  • Diagnosis of any cronic disease;
  • Daily consumption of yogurt.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louise Crovesy de Oliveira

Rio de Janeiro, 21, Brazil

Location

Related Publications (1)

  • Crovesy L, El-Bacha T, Rosado EL. Modulation of the gut microbiota by probiotics and symbiotics is associated with changes in serum metabolite profile related to a decrease in inflammation and overall benefits to metabolic health: a double-blind randomized controlled clinical trial in women with obesity. Food Funct. 2021 Mar 15;12(5):2161-2170. doi: 10.1039/d0fo02748k.

    PMID: 33565558DERIVED

Related Links

MeSH Terms

Conditions

ObesityWeight LossHyperlipidemias

Interventions

ProbioticsfructooligosaccharideGelatin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Louise C Oliveira, MD student

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

November 1, 2018

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

BR(1)