Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

NCT04095949 | Completed

• 1 other identifier: Artichoke Study
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Men and Women

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Artichokes

EXPERIMENTAL

1 day of artichokes intake

Dietary Supplement: Artichokes

Interventions

Artichokes DIETARY_SUPPLEMENT

Approximately 200 g of cooked artichokes

Artichokes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women aged 18-40 years old
• 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
• Are able to understand the nature of the study
• Able to give signed written informed consent
• Signed informed consent form

You may not qualify if:

• Metabolic disease
• Chronic disease or medications
• BMI not between 18.5 and 30
• Allergies to artichokes or other significant food allergy.
• Subjects under medication or on vitamin/dietary supplements.
• Subjects who reported participant in another study within one month before the study start
• Pregnant woman or planning to become pregnant in the next month
• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London, Department of Nutritional Sciences

London, SE1 9NH, United Kingdom

Location

Study Officials

• Ana Rodriguez-Mateos, PhD

  ana.rodriguez-mateos@kcl.ac.uk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Nutrition

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 19, 2019
• Study Start: July 17, 2019
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)