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CompletedNCT01106729Updated Oct 4, 2011

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

An interventional study of Cyanidin 3 glucoside in Metabolism and Clearance of Cyanidin 3 Glucoside, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-04.

Sponsored by University of East Anglia · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Metabolism and Clearance of Cyanidin 3 Glucoside

Keywords

  • Flavonoids
  • Anthocyanin
  • Cyanidin 3 glucoside
  • Acute feeding trial
  • Stable isotope
  • Metabolism
  • Clearance
  • Bioavailability
  • Pharmacokinetics
03

In context

Lead sponsor

University of East Anglia is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Other
    Cyanidin 3 glucoside

    Dietary Supplement: Cyanidin 3 glucoside

Interventions

  • Dietary supplementCyanidin 3 glucoside

    Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment)

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of East Anglia
    Norwich, Norfolk NR47TJ, United Kingdom
08

References and documents

Publications

  • Czank C, Cassidy A, Zhang Q, Morrison DJ, Preston T, Kroon PA, Botting NP, Kay CD. Human metabolism and elimination of the anthocyanin, cyanidin-3-glucoside: a (13)C-tracer study. Am J Clin Nutr. 2013 May;97(5):995-1003. doi: 10.3945/ajcn.112.049247. PubMed 23604435 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01106729
Lead sponsor
University of East Anglia
Collaborators
Quadram Institute Bioscience
First posted
Apr 20, 2010
Start date
Jul 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Oct 4, 2011

Study contacts

Colin Kay, PhD
principal investigator · University of East Anglia
Charles Czank, PhD
study director · University of East Anglia
Aedin Cassidy, PhD
study director · University of East Anglia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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