Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03292978
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2017-09-19
Brief Title:
An Intervention on Healthy Adults of Probiotics on Gut Flora Metabolisms of Choline
Sponsor:
Huilian Zhu
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Probiotics Intervention on Gut Flora Metabolisms of CholineA Randomized Double-Blind Control Trial
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 recordThe statistic analysis is by SPSS 230
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 recordThe statistic analysis is by SPSS 230
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None