Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

Healthy Men and Women Clinical Trial

Official title:

Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095949
• Other study ID #: Artichoke Study
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: October 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Men and Women

Intervention

Dietary Supplement:
• Artichokes
Approximately 200 g of cooked artichokes

Locations

Country	Name	City	State
United Kingdom	King's College London, Department of Nutritional Sciences	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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