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

This study has been completed.
Sponsor:
Collaborator:
Institute of Food Research
Information provided by:
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01106729
First received: April 19, 2010
Last updated: October 1, 2011
Last verified: October 2011
  Purpose

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 Intervention
Metabolism and Clearance of Cyanidin 3 Glucoside
Dietary Supplement: Cyanidin 3 glucoside

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Tracing the Path of the Plant Pigment Cyanidin-3-glucoside, Through the Human Body After Consumption

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cyanidin 3 glucoside Dietary Supplement: Cyanidin 3 glucoside
Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106729

Locations
United Kingdom
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Institute of Food Research
Investigators
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
  More Information

No publications provided

Responsible Party: Colin Kay, Chief Investigator, University of East Anglia
ClinicalTrials.gov Identifier: NCT01106729     History of Changes
Other Study ID Numbers: BB/H004963/1, R17228
Study First Received: April 19, 2010
Last Updated: October 1, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:
Flavonoids
Anthocyanin
Cyanidin 3 glucoside
Acute feeding trial
Stable isotope
Metabolism
Clearance
Bioavailability
Pharmacokinetics

ClinicalTrials.gov processed this record on October 23, 2014