Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01106729
Status:
COMPLETED
Last Update Posted:
2011-10-04
First Post:
2010-04-19
Brief Title:
Tracing the Path of an Ingested Plant Pigment Through the Human Body
Sponsor:
University of East Anglia
Organization:
University of East Anglia
Study Overview
Official Title:
Tracing the Path of the Plant Pigment Cyanidin-3-glucoside Through the Human Body After Consumption
Status:
COMPLETED
Status Verified Date:
2011-10
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:
This study will trace the path of a natural plant pigment cyanidin-3-glucoside C3G through the human body after consumption C3G is the most abundant of the naturally occurring anthocyanin family of plant pigments and is responsible for the red to purple colour of many fruits and vegetables Anthocyanins are promoted as being potentially beneficial to heart-health and also have anti-cancer properties however little is known about how the body processes these compounds after they are eaten or how they are cleared from the digestive system The investigators study aims to answer these questions and in doing so unravel how they may benefit everyones health
In this BBSRC funded study 8 healthy 18-45y male participants will be recruited to a one day feeding study lasting 8 hours to establish the routes of clearance of anthocyanins from the body After consent has been obtained participants will be screened to establish their health by NHS clinical staff Eligible participants will be asked to consume a low anthocyanin diet for 7 days and to attend a study day at the Clinical Research Trials Unit CRTU University of East Anglia Participants will attend in a fasted state at least 8h of water only and will be asked to provide a urine total morning void and faecal within the previous 72h sample Participants will then consume a C3G capsule and blood and breath samples will be collected at regular intervals after consumption 05 1 2 4 and 6 hours The capsule is roughly the size of a commercial vitamin-C tablet 500mg Participants will then return in a fasted state on the following 2 mornings to provide further urine faeces breath and blood samples Low anthocyanin meals will be provided throughout the study day and on the following 2 mornings Participants will be reimbursed for their inconvenience
In this BBSRC funded study 8 healthy 18-45y male participants will be recruited to a one day feeding study lasting 8 hours to establish the routes of clearance of anthocyanins from the body After consent has been obtained participants will be screened to establish their health by NHS clinical staff Eligible participants will be asked to consume a low anthocyanin diet for 7 days and to attend a study day at the Clinical Research Trials Unit CRTU University of East Anglia Participants will attend in a fasted state at least 8h of water only and will be asked to provide a urine total morning void and faecal within the previous 72h sample Participants will then consume a C3G capsule and blood and breath samples will be collected at regular intervals after consumption 05 1 2 4 and 6 hours The capsule is roughly the size of a commercial vitamin-C tablet 500mg Participants will then return in a fasted state on the following 2 mornings to provide further urine faeces breath and blood samples Low anthocyanin meals will be provided throughout the study day and on the following 2 mornings Participants will be reimbursed for their inconvenience
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R17228 | OTHER | University of East Anglia | None |