GreenArt: Nutrikinetics and Bioavailability Studies
ConditionNutrition, Healthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-69
SponsorFytexia
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
Dietary supplementGreenArt 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.
Dietary supplementGreenArt 4D contains 600 mg of GreenArt
Placebo
Dietary supplementPlacebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.
Treatment groups
10 Participants
are divided into 3 treatment groupsGroup A: GreenArt DExperimental treatment 1 intervention
Group B: GreenArt 4DExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-ingestion) to 24 hour post-ingestion2
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.
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-ingestion3
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.
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-ingestion4
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.
Time frame
Baseline (pre-ingestion) to 48 hour post-ingestion Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: