Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.

Universidade Federal de Santa Catarina

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Synbiotic; Other: Placebo; Dietary Supplement: Prebiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02158676

96156587

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 years and less than 65 years
• Body mass index (BMI)> 40kg/m2 or> 35kg/m2 with at least one comorbidity
• Failure in the non-pharmacological and pharmacological treatment.

Exclusion criteria

• Significant intellectual limitations without adequate family support.
• Uncontrolled psychiatric disorder.
• Alcohol dependence and / or illicit drugs dependence.
• Current use of anti-inflammatory drugs and / or antibiotics and / or immunosuppressants
• Display intolerance prebiotics and / or probiotics and / or symbiotic
• Having made use of prebiotic and / or probiotic and / or symbiotic prior to the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups, including a placebo group

Prebiotic

Experimental group

Description:

6 g/day of prebiotic (fructooligosaccharides) for 15 days.

Treatment:

Dietary Supplement: Prebiotic

Synbiotic

Experimental group

Description:

6 g/day of synbiotic (fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019) for 15 days.

Treatment:

Dietary Supplement: Synbiotic

Placebo

Placebo Comparator group

Description:

6 g/day of placebo (maltodextrin) for 15 days.

Treatment:

Other: Placebo