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An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline

Probiotics Intervention on Gut Flora Metabolisms of Choline:A Randomized Double-Blind Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03292978
Enrollment
40
Registered
2017-09-26
Start date
2017-07-01
Completion date
2018-12-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DIETARY_SUPPLEMENTnon-probiotic control

The placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention.

DIETARY_SUPPLEMENTprobiotics intervention

The probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks.

Sponsors

Huilian Zhu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy males at 18 to 30 years old; * Free from antibiotics and probiotic products for at least 1 month; * Willing to participate in the study, consume the test product and perform all measurements.

Exclusion criteria

* Sever physical diseases; * Intolerance to probiotics or eggs

Design outcomes

Primary

MeasureTime frameDescription
choline metabolites4 weeks laterThe metabolites of choline before and after the intervention including free choline, betaine, TMA, TMAO will be measured by UPLC/MS.

Secondary

MeasureTime frameDescription
intestinal microbiota composition4 weeks laterThe intestinal microbiota composition of feces before and after the intervention will be examined by 16S-DNA.
anthropometry measurement4 weeks laterThe height and weight which are combined to report BMI in kg/m\^2 will be measured before and after the intervention by professional investigators.
blood biochemical markers4 weeks laterOvernight 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026