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Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095949
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

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.


Condition or disease Intervention/treatment Phase
Healthy Men and Women Dietary Supplement: Artichokes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals
Actual Study Start Date : July 17, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Arm Intervention/treatment
Experimental: Artichokes
1 day of artichokes intake
Dietary Supplement: Artichokes
Approximately 200 g of cooked artichokes




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095949


Locations
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United Kingdom
King's College London, Department of Nutritional Sciences
London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Ana Rodriguez-Mateos, PhD ana.rodriguez-mateos@kcl.ac.uk
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Responsible Party: Dr Ana Rodriguez-Mateos, Lecturer in Nutrition, King's College London
ClinicalTrials.gov Identifier: NCT04095949    
Other Study ID Numbers: Artichoke Study
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No