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Micro-nutritional Status and Gut Microbiota in Morbidly Obese Patients Before and After Gastric Bypass With and Without Micro-nutritional Supplementation

ClinicalTrials.gov · COMPLETED, 2012

90 participants

Abstract

An intervention study design in 90 obese patients will be used. Nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. During this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery.

Subjects will be than randomized in 2 sub-groups:

A. patients receiving a standard healthy diet without micro-nutriments' supplementation; B. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation

Conditions: Obesity, Bariatric Surgery Candidate.

Primary outcome: Vitamins A levels; Vitamin E levels; Selenium levels; Zinc levels; Copper levels; Glutathione peroxidise; Superoxide dismutase; Iron levels.

Enrollment: 90 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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