Tracing the Path of an Ingested Plant Pigment Through the Human Body

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01106729
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : October 4, 2011
Quadram Institute
Information provided by:
University of East Anglia

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

Condition or disease Intervention/treatment Phase
Metabolism and Clearance of Cyanidin 3 Glucoside Dietary Supplement: Cyanidin 3 glucoside Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tracing the Path of the Plant Pigment Cyanidin-3-glucoside, Through the Human Body After Consumption
Study Start Date : July 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Cyanidin 3 glucoside Dietary Supplement: Cyanidin 3 glucoside
Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males
  • 18-45 years old
  • No allergies to fruits or vegetables containing anthocyanins or foods to be provided on the study day
  • Those agreeing to restrict dietary intake of rich sources of anthocyanins
  • Those agreeing to comply with a biological sampling protocol and have cannula inserted for the collection of blood samples on the study day
  • Those agreeing to record their dietary intake over 3 days (1 weekend day and 2 week days)

Exclusion Criteria:

  • Those judged by the study clinical staff (to be appointed) to have biochemical and / or haematological screening results which reflect compromised health or that may affect the study analysis
  • Participants with a body mass index of less than 18.5 or greater than 30
  • Taking food / dietary supplements containing anthocyanins e.g. grape seed extract, acai berry (unless prepared to cease intake during, and 7 days preceding the study)
  • Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/material
  • Smokers or those who have ceased smoking within 12 months.
  • Habitual drinkers of more than 4 units* of alcohol per day or more than 21 units per week (NHS guidelines). *A unit of alcohol is approximately equivalent to a half pint of full strength beer or cider or a small glass of wine (100ml) or a single measure (25ml) of spirits
  • Having donated blood in the last month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01106729

United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Quadram Institute
Principal Investigator: Colin Kay, PhD University of East Anglia
Study Director: Charles Czank, PhD University of East Anglia
Study Director: Aedin Cassidy, PhD University of East Anglia

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Colin Kay, Chief Investigator, University of East Anglia Identifier: NCT01106729     History of Changes
Other Study ID Numbers: BB/H004963/1
R17228 ( Other Identifier: University of East Anglia )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by University of East Anglia:
Cyanidin 3 glucoside
Acute feeding trial
Stable isotope