GreenArt: Nutrikinetics and Bioavailability Studies

NCT07681310 | Not Yet Recruiting

• 1 other identifier: GREENKBA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (6)

• Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo

  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

  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

  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

  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

  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

  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

Study Arms (3)

GreenArt D

EXPERIMENTAL

This arm receives 150 mg of GreenArt, a baccharis-type propolis phenolic extract

Dietary Supplement: GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.

GreenArt 4D

EXPERIMENTAL

This arm receives 600 mg of GreenArt, a baccharis-type propolis phenolic extract

Dietary Supplement: GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.

Placebo

PLACEBO COMPARATOR

This arm receives 150 mg of mix carriers of the GreenArt ingredient, a baccharis-type propolis phenolic extract

Dietary Supplement: Placebo

Interventions

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 D contains 150 mg of GreenArt

GreenArt D

Placebo DIETARY_SUPPLEMENT

Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.

Placebo

GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids. DIETARY_SUPPLEMENT

GreenArt 4D contains 600 mg of GreenArt

GreenArt 4D

Eligibility Criteria

• Age: 25 Years - 69 Years
• Gender Eligibility Details: Male and female with 40% min. and 60% max. of each sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fytexia: lead

Study Sites (1)

UCAM Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Flavonoids

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Julien Cases, PhD

CONTACT

+33467219098; jcases@biotexia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: June 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)