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Completed

NCT Number: NCT04095949

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.

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Key information

Conditions

Healthy Men and Women

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London, Department of Nutritional Sciences

London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Artichokes

Dietary Supplement

Approximately 200 g of cooked artichokes

Primary outcomes

  1. Change in qualitative identification of polyphenols and their metabolites of artichokes in plasma between baseline and 24h post consumption

    Time frame: Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours

    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).

  2. Change in qualitative identification of polyphenols and their metabolites of artichokes in urine between baseline and 24h post consumption

    Time frame: Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours

    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).

  3. Change in the plasmatic concentration of polyphenols (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption

    Time frame: Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours

    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).

  4. Change in the concentration of polyphenols in urine (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption

    Time frame: Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours

    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).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2019
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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