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Completed

NCT Number: NCT02505854

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Louise Crovesy de Oliveira

Rio de Janeiro, 21, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

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

Other names: Bifidobacterium lactis

Symbiotic

Dietary Supplement

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

Other names: Bifidobacterium lactis and fructooligosaccharide

Placebo

Dietary Supplement

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

Other names: Gelatin

Primary outcomes

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

    Time frame: Baseline and 60 days and 15 days after the end of the intervention

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

Secondary outcomes

  1. Effect of probiotic and symbiotic on blood glucose

    Time frame: Baseline, 60 days and 15 days after the end of the intervention

    Determine and comparing the blood glucose in plasma before and after intervention

  2. Effect of probiotic and symbiotic on insulin resistance

    Time frame: Baseline and 60 days

    Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.

  3. Effect of probiotic and symbiotic on lipid profile

    Time frame: Baseline and 60 days

    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.

  4. Effect probiotic and symbiotic on blood pressure

    Time frame: Baseline,60 days and 15 days after intervention conclusion

    Determine blood pressure and evaluate whether the intervention improvement blood pressure.

  5. Effect of probiotic and symbiotic on gut microbiota composition

    Time frame: Baseline, 60 days and 15 days after intervention conclusion

    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

  6. Effect of probiotic and symbiotic on stool consitency by Bristol scale

    Time frame: Baseline,60 days and 15 days after intervention conclusion

    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.

  7. Effect of probiotic and symbiotic on gastrointestinal symptons

    Time frame: Baseline,60 days and 15 days after intervention conclusion

    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.

  8. Effect of probiotic and symbiotic on metabolomic profile

    Time frame: Baseline and 60 days

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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