An interventional study of probiotics intervention and non-probiotic control in Healthy, sponsored by Huilian Zhu. Completed at 1 site in China. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Huilian Zhu · Not applicable, Interventional, and Basic science
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.
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.
Huilian Zhu is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
1. The probiotic is provided in sachets as a 2g powder dried with corn starch. 2. The powder is orally taken once daily for 4 weeks. 3. The powder contains totally 11 log 10 colony forming units(CFU) of probiotics. 4. The types of probiotics are Lactobacillus.rhamnosus, Lactobacillus.acidophilus, Bifidobacteria.animalis and Bifidobacteria.longum.
Dietary Supplement: probiotics intervention
The placebo is corn starch alone provided and the shape, color, weight,flavor and taste are same with the powder of probiotics intervention.
Dietary Supplement: non-probiotic control
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.
choline metabolites
The metabolites of choline before and after the intervention including free choline, betaine, TMA, TMAO will be measured by UPLC/MS.
Time frame: 4 weeks later
intestinal microbiota composition
The intestinal microbiota composition of feces before and after the intervention will be examined by 16S-DNA.
Time frame: 4 weeks later
anthropometry measurement
The height and weight which are combined to report BMI in kg/m\^2 will be measured before and after the intervention by professional investigators.
Time frame: 4 weeks later
blood biochemical markers
Overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc) and fasting blood glucose were measured by colorimetric methods using a Hitachi 7600-010 automated analyzer.
Time frame: 4 weeks later
Ran from Jul 2017 to primary completion in Dec 2017, 5 months.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Huilian Zhu