- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07681310
GreenArt: Nutrikinetics and Bioavailability Studies
June 26, 2026 updated by: Fytexia
Baccharis-type Propolis Extract, GreenArt: Nutrikinetics and Bioavailability Studies
The aim of this study is to investigate phenolic compounds from GreenArt, a baccharis-type propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and metabolic profile over 48h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS).
The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
- Dietary supplement: GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
- Dietary supplement: GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
- Dietary supplement: Placebo
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julien Cases, PhD
- Phone Number: +33467219098
- Email: jcases@biotexia.com
Study Locations
-
-
Murcia
-
Guadalupe, Murcia, Spain, 30107
- UCAM Universidad Católica San Antonio de Murcia
-
Contact:
- Linda H. Chung, PhD
- Phone Number: + 34 968 278 611
- Email: lhchung@ucam.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male and female with 40% min. and 60% max. of each sex.
- Aged 25 to 69 years old
- BMI range (18.5 - 29.99)
- In good general health as evidenced by medical history
- Ability to take oral supplementation and be willing to adhere to the regimen
- Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration
Exclusion Criteria:
- Current use of any medication or food supplement
- Antibiotic use less than 12 weeks before the study
- Pregnancy or lactation
- Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
- Metabolic disorders or any kind of disease
- Current smoker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GreenArt D
This arm receives 150 mg of GreenArt, a baccharis-type propolis phenolic extract
|
GreenArt D contains 150 mg of GreenArt
|
|
Experimental: GreenArt 4D
This arm receives 600 mg of GreenArt, a baccharis-type propolis phenolic extract
|
GreenArt 4D contains 600 mg of GreenArt
|
|
Placebo Comparator: Placebo
This arm receives 150 mg of mix carriers of the GreenArt ingredient, a baccharis-type propolis phenolic extract
|
Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) to 24 hour post-ingestion
|
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame.
Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS.
Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives.
For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured.
|
Baseline (pre-ingestion) to 24 hour post-ingestion
|
|
Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
|
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame.
Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS.
Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives.
For each identified and quantified metabolite the maximal concentration in nmol/L is measured.
|
Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
|
|
Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
|
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame.
Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS.
Targeted metabolites are prenylated phenolic acids, phenolic acids, and flavonoids derivatives.
For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.
|
Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
|
|
Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) to 48 hour post-ingestion
|
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame.
Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS.
Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives.
For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured.
|
Baseline (pre-ingestion) to 48 hour post-ingestion
|
|
Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
|
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame.
Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS.
Targeted metabolites are penylated phenolic acids, phenolic acids and flavonoids derivatives.
For each identified and quantified metabolite the maximal concentration in nmol/L is measured.
|
Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
|
|
Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Time Frame: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
|
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame.
Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS.
Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives.
For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.
|
Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
June 26, 2026
First Submitted That Met QC Criteria
June 26, 2026
First Posted (Actual)
July 2, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 26, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GREENKBA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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