Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536947
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2021-12-14
Brief Title:
Micronutrient Bioavailability From Wheat
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Micronutrient Bioavailability From Wheat
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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 purpose of this study is to determine if physical disruption of wheat aleurone cell walls micro-milling increases micronutrient availability
Detailed Description:
This research project is a short-term dietary intervention study to investigate the bio-availability of iron and zinc from wheat Approximately 50 of iron and 30 of zinc in the United Kingdom diet is provided by cereals and cereal products eg bread and breakfast cereals The localisation of both iron and zinc metals in wheat is largely confined to the aleurone layer a single layer of cells located between the centre endosperm and outer layers testa and pericarp The aleurone layer is removed during the production of white flour For this reason since 1953 it has been mandatory to add iron to flours at the mill to restore iron to levels present in wholegrain flour The Bread and Flour Regulations 1998
The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling a process which reduces particle size of flour from approximately 100μm to 10μm ruptures the aleurone cell walls and increases iron availability ie the amount absorbed by intestinal cells compared with flour produced using standard milling techniques which does not break down the aleurone layer
Based on these initial findings the current study therefore has 2 main aims
i to determine whether physical disruption of the aleurone by micro-milling in wholegrain flour increases iron and zinc availability from wholegrain bread
ii to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread
The investigators have shown that aleurone cells are resistant to physical disruption and digestion as they pass along the gastrointestinal tract and are excreted intact in faeces The investigators believe that disruption of wheat aleurone cell walls prior to food manufacturing would therefore increase iron and zinc availability Using wholegrain flour and purified wheat aleurone flour the investigators have shown that micro-milling a process which reduces particle size of flour from approximately 100μm to 10μm ruptures the aleurone cell walls and increases iron availability ie the amount absorbed by intestinal cells compared with flour produced using standard milling techniques which does not break down the aleurone layer
Based on these initial findings the current study therefore has 2 main aims
i to determine whether physical disruption of the aleurone by micro-milling in wholegrain flour increases iron and zinc availability from wholegrain bread
ii to determine whether addition of micro-milled aleurone flour to white flour increases iron availability from white bread
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