GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.Placebo
GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.: GreenArt D contains 150 mg of GreenArt
GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.: GreenArt 4D contains 600 mg of GreenArt
Placebo: Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.
Study 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.
Eligibility
Sex
ALL
Min age
25 Years
Max age
69 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male and female with 40% min. and 60% max. of each sex.
4. Aged 25 to 69 years old
5. BMI range (18.5 - 29.99)
6. In good general health as evidenced by medical history
7. Ability to take oral supplementation and be willing to adhere to the regimen
8. Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration
Exclusion Criteria:
1. Current use of any medication or food supplement
2. Antibiotic use less than 12 weeks before the study
3. Pregnancy or lactation
4. Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
5. Metabolic disorders or any kind of disease
6. Current smoker
Primary outcome measure(s)
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo — 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.
Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo — 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.
Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo — 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.
Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo — 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.
Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo — 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.
Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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