Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

A number of studies have reported the presence of polyphenolic compounds in artichokes, being the most abundant the caffeoylquinic acids (CQAs), which are esters between quinic acid and the hydroxycinnamate caffeic acid. The fate of artichoke polyphenols in humans after ingestion is currently unknown. The acute study will provide novel information on the bioavailability and metabolism of artichoke polyphenols, which will give important insights to understand the potential health benefits of artichoke consumption.

Health men and women participants (n=8) aged between 18 to 40 years old will be recruited. Participants will consume a normal ration of artichokes once. The participants will provide the investigators with urine and blood samples for polyphenol analysis at baseline and at different time points until 24 hours.

Study Overview

• Status: Completed
• Conditions: Healthy Men and Women
• Intervention / Treatment: Dietary supplement: Artichokes

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9NH
    • King's College London, Department of Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy men and women aged 18-40 years old
2. Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
3. Are able to understand the nature of the study
4. Able to give signed written informed consent
5. Signed informed consent form

Exclusion Criteria:

1. Metabolic disease
2. Chronic disease or medications
3. BMI not between 18.5 and 30
4. Allergies to artichokes or other significant food allergy.
5. Subjects under medication or on vitamin/dietary supplements.
6. Subjects who reported participant in another study within one month before the study start
7. Pregnant woman or planning to become pregnant in the next month
8. Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Artichokes; 1 day of artichokes intake	Dietary supplement: Artichokes; Approximately 200 g of cooked artichokes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in qualitative identification of polyphenols and their metabolites of artichokes in plasma between baseline and 24h post consumption	Change in polyphenols and their metabolites in plasma between baseline and 24h post consumption will be measured by identifying qualitatively metabolites from artichokes at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).	Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours
Change in qualitative identification of polyphenols and their metabolites of artichokes in urine between baseline and 24h post consumption	Change in polyphenols and their metabolites in urine between baseline and 24h post consumption will be measured by identifying qualitatively metabolites from artichokes at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).	Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours
Change in the plasmatic concentration of polyphenols (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption	Bioavailability and metabolism from artichoke polyphenols will be studied by evaluating changes in artichoke polyphenols concentration (nanomol/L) in plasma samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).	Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours
Change in the concentration of polyphenols in urine (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption	Metabolism and excretion from artichoke polyphenols will be studied by evaluating changes in artichoke polyphenols concentration (nanomol/L) in urine samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).	Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours

Collaborators and Investigators

• Sponsor: King's College London
• Investigators: Principal Investigator: Ana Rodriguez-Mateos, PhD, ana.rodriguez-mateos@kcl.ac.uk

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Artichoke Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No