Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women

Obesity Clinical Trial

Official title:

Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505854
• Other study ID #: CEP 104-14
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2018

Study information

• Verified date: December 2019
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women;

• Adult;

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

Exclusion Criteria:

• Pregnancy or nursing;

• Smokers;

• Drinkers;

• Use of drug or phytotherapic;

• Diagnosis of any cronic disease;

• Daily consumption of yogurt.

Related Conditions & MeSH terms

• Body Weight
• Hyperlipidemias
• Obesity

Intervention

Dietary Supplement:
• Probiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
• Symbiotic
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
• Placebo
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin

Locations

Country	Name	City	State
Brazil	Louise Crovesy de Oliveira	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of probiotic and symbiotic on blood glucose	Determine and comparing the blood glucose in plasma before and after intervention	Baseline, 60 days and 15 days after the end of the intervention
Secondary	Effect of probiotic and symbiotic on insulin resistance	Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.	Baseline and 60 days
Secondary	Effect of probiotic and symbiotic on lipid profile	Compare lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, triglyceride) in serum of blood before and after intervention and evaluate whether the intervention improvement in this parameter.	Baseline and 60 days
Secondary	Effect probiotic and symbiotic on blood pressure	Determine blood pressure and evaluate whether the intervention improvement blood pressure.	Baseline,60 days and 15 days after intervention conclusion
Secondary	Effect of probiotic and symbiotic on gut microbiota composition	Determine and comparing the amount filos (Fimicutes, Bacteroidetes, Actinobacteria, Verrucomicrobia e Proteobacteria) in gut microbiota and whether the change in microbiota composition continue after stop probiotic and symbiotic intake	Baseline, 60 days and 15 days after intervention conclusion
Secondary	Effect of probiotic and symbiotic on stool consitency by Bristol scale	Determine and comparing the stool consistency by Bristol scale. The Bristol scale is composed of 7 different stool consistency, being 1 and 2 lumpy, 3 and 4 normal, 5 to 7 loose.	Baseline,60 days and 15 days after intervention conclusion
Secondary	Effect of probiotic and symbiotic on gastrointestinal symptons	Evaluate the presence of gastrointestinal symptoms related to the probiotic and symbiotic. The gastrointestinal symptoms analyzed were abdominal pains, abdominal distension and abdominal discomfort, flatus, borborygmus using the Likert scale of 5 point, which 0 is absence of symptom and 4 is every day.	Baseline,60 days and 15 days after intervention conclusion
Secondary	Effect of probiotic and symbiotic on metabolomic profile	Determine and comparing change in metabolomic profile before and after intervention. The metabolomic profile was evaluated in the serum of blood Bruker DRX 500 MHz equipment (Bruker Spectrospin, Karlsruhe, Germany) generating hydrogen isotope 1 (1H)-NMR spectra, that was compared to database Human Metabolome Data Base.	Baseline and 60 days

External Links

•   Institute of Nutrition Josué de Castro