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| Name | Class |
|---|---|
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin |
|
| Symbiotic | Active Comparator | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide |
|
| Placebo | Placebo Comparator | Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effect of probiotic and symbiotic on insulin resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise C Oliveira, MD student | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louise Crovesy de Oliveira | Rio de Janeiro | 21 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33565558 | Derived | 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. |
| Label | URL |
|---|---|
| Institute of Nutrition Josué de Castro | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C116580 | fructooligosaccharide |
| D005780 | Gelatin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Symbiotic | Dietary Supplement | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide |
|
|
| Placebo | Dietary Supplement | Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin |
|
|
Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter. |
| Baseline and 60 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D019602 |
| Food and Beverages |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |