An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to examine the effects of probiotics intervention on choline
      metabolites and intestinal microbiota composition using a randomized double blind clinical
      trial. Also, we proposed to explore the real-time change of choline metabolites after
      probiotics intervention through a PC challenge test. Our study will clarify the biochemical
      pathway involved in metabolic diseases and hope to provide a new targeted-preventive and
      therapeutic strategy for chronic metabolic diseases.
    

Detailed description: 
      Dietary choline (mainly refer to phosphatidylcholine, PC) produce trimethylamine (TMA)
      through the action of gut flora in vivo. TMA then readily absorbed into systemic circulation
      and oxidized by hepatic flavin monoxygenases (FMO3) to trimethylamine-N-oxide (TMAO). The
      elevated levels of circulating TMAO is identified as a risk factor for the prevalence and
      development of metabolic diseases such as cardiovascular diseases and nonalcoholic fatty
      liver diseases. Targeting gut flora for reducing TMAO may be a promising approach for
      preventing chronic metabolic diseases. Recent studies found that some strains representing
      two different phyla (Firmicutes and Proteobacteria) are capable of producing TMA from choline
      in vitro. On the other hand, TMA intervention can change the structure of intestinal flora,
      reducing the abundance of bifidobacterium and lactobacillus. Probiotics can improve the
      ecological balance of the gut flora, which might be beneficial to human health and disease
      prevention. However, whether probiotics could inhibit the TMA-producing bacterias and reduce
      the TMA and TMAO levels through balancing the gut flora was unclear.

      In order to explore whether probiotics can reduce the TMA and TMAO levels, we are proposed to
      recruit 50 volunteers aged from 18-30 years old to participate in the randomized double-blind
      trial. The volunteers are randomized allocated into different intervention groups. The
      probiotics intervention group is provided once daily orally-taken powder in a sachet, which
      contains 4 strains of probiotics. The non-probiotic control is provided with a powder without
      probiotics , but has same look, color, taste, flavor and weight as the probiotics
      intervention group. A PC challenge test will be hold before and after the 4 weeks
      intervention. The blood and fecal sample will be collected before and after the trial and
      analyzed by appropriate method. The dietary assessment is assessed by a 3-day dietary
      record.The statistic analysis is by SPSS 23.0.
    

Intervention name(s): probiotics intervention; non-probiotic control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks.; The placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science