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Not yet recruiting NCT07681310

GreenArt: Nutrikinetics and Bioavailability Studies

No phase Interventional Nutrition, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Nutrition, Healthy. Basic parameters: 25 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Baccharis-type Propolis Extract, GreenArt: Nutrikinetics and Bioavailability Studies

Overview

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.

Interventions

  • 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 D contains 150 mg of GreenArt
  • Dietary supplement 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
  • Dietary supplement Placebo
    Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Spain · 1 center
  • UCAM Universidad Católica San Antonio de Murcia — Guadalupe

Identifiers

NCT: NCT07681310 · GREENKBA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗