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

NCT ID: NCT01106729

Last Updated: 2011-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-09-30

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

Conditions

Metabolism and Clearance of Cyanidin 3 Glucoside

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cyanidin 3 glucoside

Group Type: OTHER

Cyanidin 3 glucoside

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Cyanidin 3 glucoside

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Quadram Institute Bioscience

OTHER

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

University of East Anglia

Principal Investigators

Colin Kay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Charles Czank, PhD

Role: STUDY_DIRECTOR

University of East Anglia

Aedin Cassidy, PhD

Role: STUDY_DIRECTOR

University of East Anglia

Locations

University of East Anglia

Norwich, Norfolk, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23604435 (View on PubMed)

Other Identifiers

R17228

Identifier Type: OTHER

Identifier Source: secondary_id

BB/H004963/1

Identifier Type: -

Identifier Source: org_study_id