Tracing the Path of an Ingested Plant Pigment Through the Human Body
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 19, 2010 | ||||||||||||
| Last Updated Date | October 1, 2011 | ||||||||||||
| Start Date ICMJE | July 2011 | ||||||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
The outcome measure for this study is the measure of the total amount of the 'heavy' label (which was incorporated into the C3G) in the blood, urine, faeces and breath samples in the 48 hours following consumption. [ Time Frame: 72 hours ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01106729 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
The secondary outcome measures is to identify the metabolites of C3G and the tertiary outcome measure is to establish the rates of clearance of both the heavy label and the identified metabolites. [ Time Frame: 72 hours ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Tracing the Path of an Ingested Plant Pigment Through the Human Body | ||||||||||||
| Official Title ICMJE | Tracing the Path of the Plant Pigment Cyanidin-3-glucoside, Through the Human Body After Consumption | ||||||||||||
| 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 everyone's 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 (0.5, 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 |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Metabolism and Clearance of Cyanidin 3 Glucoside | ||||||||||||
| Intervention ICMJE | Dietary Supplement: Cyanidin 3 glucoside
Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment) |
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| Study Arm (s) | Cyanidin 3 glucoside
Intervention: Dietary Supplement: Cyanidin 3 glucoside |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 8 | ||||||||||||
| Completion Date | September 2011 | ||||||||||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||
| Ages | 18 Years to 45 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United Kingdom | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01106729 | ||||||||||||
| Other Study ID Numbers ICMJE | BB/H004963/1, R17228 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Colin Kay, Chief Investigator, University of East Anglia | ||||||||||||
| Study Sponsor ICMJE | University of East Anglia | ||||||||||||
| Collaborators ICMJE | Institute of Food Research | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of East Anglia | ||||||||||||
| Verification Date | October 2011 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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