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The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.
The study will recruit patients submitted to roux-en-y gastric bypass. Individuals that meet the inclusion criteria will be randomized by means of a computer program on three study groups: 1) Prebiotic group: Oral supplementation with 6g/day of prebiotic for 15 days. 2) Synbiotic group: Oral supplementation with 6g/day of synbiotic for 15 days. 3) Placebo group (control): Oral supplementation with 6g/day of placebo (maltodextrin) for 15 days. Will be assessed the effects of supplementation on the plasma cytokines, plasma lipopolysaccharide (bacterial endotoxin), plasma cellular fatty acid profile, metabolic parameters (lipid profile, glycemic status and insulin resistance) and nutritional status. Blood samples will be collected before the surgery and the supplementation will begin 30 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic | Experimental | 6 g/day of prebiotic (fructooligosaccharides) for 15 days. |
|
| Synbiotic | Experimental | 6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days. |
|
| Placebo | Placebo Comparator | 6 g/day of placebo (maltodextrin) for 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic | Dietary Supplement | Fructooligosaccharides |
| |
| Synbiotic |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IL-1 beta concentrations | Will be evaluated IL-1 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in IL-6 concentrations | Will be evaluated IL-6 beta plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in TNF-alpha concentrations | Will be evaluated TNF-alpha plasma concentrations in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nutritional status | Will be assessed anthropometric measures: weight and height (baseline, 30 and 45 days after surgery) for the classification of nutritional status according to BMI | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Fernandes, Master's | Universidade Federal de Santa Catarina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Polydoro Ernani de São Thiago | Florianópolis | Santa Catarina | 88040-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25909598 | Result | Fernandes R, Beserra BT, Mocellin MC, Kuntz MG, da Rosa JS, de Miranda RC, Schreiber CS, Frode TS, Nunes EA, Trindade EB. Effects of Prebiotic and Synbiotic Supplementation on Inflammatory Markers and Anthropometric Indices After Roux-en-Y Gastric Bypass: A Randomized, Triple-blind, Placebo-controlled Pilot Study. J Clin Gastroenterol. 2016 Mar;50(3):208-17. doi: 10.1097/MCG.0000000000000328. |
| Label | URL |
|---|---|
| URL for full text article | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Dietary Supplement |
Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 |
|
| Placebo | Other | Maltodextrin |
|
| Change in risk of inflammatory and nutritional complications |
Will be calculated the CRP/albumin ratio, as proposed by Correa et al (2002), using the cutoff points proposed by the same author for the classification of high, medium, decreased or no risk. |
| Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation) |
| Change in fasting glucose concentrations | Will be assessed the plasma concentrations of fasting glucose in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in fasting insulin concentrations | Will be assessed the plasma concentrations of fasting insulin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in HOMA-IR index | Will be assessed the HOMA-IR index in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in glycated hemoglobin | Will be evaluated glycated hemoglobin in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in lipid profile | Will be evaluated lipid profile in baseline which corresponds to the day that the patient will undergo surgery, in 30 days after surgery (before supplementation) and in 45 days after surgery (after supplementation). | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in plasma monounsaturated fatty acids | Will be assessed the proportion (%) of plasma monounsaturated fatty acids | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in plasma polyunsaturated fatty acids | Will be assessed the proportion (%) of plasma polyunsaturated fatty acids | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| Change in plasma saturated fatty acids | Will be assessed the proportion (%) of plasma saturated fatty acids | Baseline (before surgery); Day 30 (after surgery, before supplementation); Day 45 (after surgery, after supplementation). |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D019936 | Probiotics |