Clinical trial NCT04095949: Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals
Official title: Absorption, Metabolism and Excretion of Artichoke Polyphenols in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men and Women
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Change in qualitative identification of polyphenols and their metabolites of artichokes in plasma between baseline and 24h post consumption
timeFrame: Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours
measure: Change in qualitative identification of polyphenols and their metabolites of artichokes in urine between baseline and 24h post consumption
timeFrame: Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours
measure: Change in the plasmatic concentration of polyphenols (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption
timeFrame: Baseline, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours and 24 hours
measure: Change in the concentration of polyphenols in urine (nanomol/L) and their metabolites of artichokes between baseline and 24h post consumption
timeFrame: Baseline, 0-2 hours, 2-4 hours, 4-8 hours and 8-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London, Department of Nutritional Sciences
Study officials:
affiliation: ana.rodriguez-mateos@kcl.ac.uk
name: Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: