The impact of probiotics' administration on glycemic control, body composition, gut microbiome, mitochondria, and other hormonal signals in adolescents with prediabetes - A randomized, controlled trial study protocol

Contemp Clin Trials Commun. 2018 Jun 2;11:55-62. doi: 10.1016/j.conctc.2018.06.002. eCollection 2018 Sep.

Abstract

Background: Recent studies have demonstrated that a significant proportion of adolescents exhibit abdominal obesity in early-middle adolescence, and impaired glucose metabolism. Dysregulation of glucose metabolism is aggravated by the existing osteosarcopenia not only in obese but also in overweight youth. Biochemical inflammation, derived from glucose metabolism dysregulation, in combination with increased stress levels lead to the accumulation of reactive oxygen species, also known as ROS, which seem to afflict the integrity of the gastrointestinal wall, gut mucosa, and commensal, intestinal gut microflora. The current scientific protocol aims to assess the administration of probiotics in prediabetic adolescents in relation with their glycemic control, body composition, and intestinal microbiome.

Methods/design: This is a study protocol of a two-armed RCT, that recruits adolescents with prediabetes, who will receive either a 4-month, life-style intervention, or a life-style intervention along with a probiotic supplement. The primary outcome is the differences in gut microbiome synthesis, body composition analysis parameters, and concentrations of hormones, before and after the intervention.

Discussion: This study aims to halt the progression of obesity and diabetes and aspires to contribute new evidence for upgraded treatment of obesity and diabetes.

Trial registration: Australian New Zealand Clinical Trial Registry (ACTRN12615000470594).

Keywords: Gut barrier; Gut microbiome; Mitochondrion; Prediabetes; Probiotics; RCT.