Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905822
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-06-06
Brief Title:
DIetary plAnt Extracts Colonic MicrObes and Apoe geNetics Interactions stuDy
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
DIetary plAnt Extracts Colonic MicrObes and Apoe geNetics Interactions stuDy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
DIAMOND
Brief Summary:
This study will involve donating a salivary sample and a faecal stool sample These will be analysed in the laboratory to determine the forms of the APOE gene you are carrying your APOE genotype and the response of the bacteria in your colon to reactive compounds extracted from edible plants dietary bioactives
Detailed Description:
In an ageing population the incidence of dementia is rapidly increasing and poses a significant financial societal and above all personal burden Aside from ageing the type of APOE gene an individual carries their APOE genotype is the greatest risk factor for the development of cognitive decline It has been shown that the APOE genotype of an individual influences the types of bacteria present in the colon The bacteria which reside in the colon have recently emerged as a significant contributor to nutrition and health and have been suggested to influence brain functioning through complex connections between the gut and the brain
Nutrition is considered important for brain function throughout life and findings from recent laboratory and human observational studies have suggested that reactive compounds extracted from edible plants dietary bioactives can not only improve brain function but they can change the function and composition of gut bacteria Dietary bioactives are a range of natural compounds found in great concentrations within fruits and vegetables which influence the body An example of a dietary bioactive is a group of compounds known as polyphenols These polyphenols are described as antioxidants and are found in various foods including berries tea and cocoa
There have been no previous studies looking at the impact of dietary bioactives on the microbiome of each APOE genotype and the metabolites produced by each of these bacteria We aim with the current study to identify how dietary bioactives from a range of plant tissue could influence gut bacteria present and the metabolites produced by the bacteria in each APOE group and the compounds produced by these bacteria
What will the study involve Once we have established a potentially suitable participant they will be sent a salivary sampling kit Depending on the genotype age and sex participants will be requested to donate a stool sample The stool will be processed in a colon model with cocoa polyphenol added
The study involves the following stages
1 Online screening consenting and collection of basic information
2 Collection of a salivary sample in person at the Clinical Research Facility or home and return to the labs via pre-paid postal mail
3 Confirmation of eligibility to donate stool samples
4 Collection of stool samples on the same day as sample collection Returning the sample in person or through the pre-paid postal system
Nutrition is considered important for brain function throughout life and findings from recent laboratory and human observational studies have suggested that reactive compounds extracted from edible plants dietary bioactives can not only improve brain function but they can change the function and composition of gut bacteria Dietary bioactives are a range of natural compounds found in great concentrations within fruits and vegetables which influence the body An example of a dietary bioactive is a group of compounds known as polyphenols These polyphenols are described as antioxidants and are found in various foods including berries tea and cocoa
There have been no previous studies looking at the impact of dietary bioactives on the microbiome of each APOE genotype and the metabolites produced by each of these bacteria We aim with the current study to identify how dietary bioactives from a range of plant tissue could influence gut bacteria present and the metabolites produced by the bacteria in each APOE group and the compounds produced by these bacteria
What will the study involve Once we have established a potentially suitable participant they will be sent a salivary sampling kit Depending on the genotype age and sex participants will be requested to donate a stool sample The stool will be processed in a colon model with cocoa polyphenol added
The study involves the following stages
1 Online screening consenting and collection of basic information
2 Collection of a salivary sample in person at the Clinical Research Facility or home and return to the labs via pre-paid postal mail
3 Confirmation of eligibility to donate stool samples
4 Collection of stool samples on the same day as sample collection Returning the sample in person or through the pre-paid postal system
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