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Completed

NCT Number: NCT06062511

Poplar-type Propolis Dry Extract ESIT12 : Nutrikinetic and Bioavailability Studies

The aim of this study is to investigate phenolic compounds from ESIT12, a poplar-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.

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Key information

Conditions

Nutrition, Healthy

Age range

25 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESIT12 D

Dietary Supplement

ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 D contains 400 mg of ESIT12

ESIT12 4D

Dietary Supplement

ESIT12 is a poplar-type propolis powder extract containing phenolic compounds from flavonoids and phenolic acids family. ESIT12 4D contains 1600 mg of ESIT12

Placebo

Dietary Supplement

Placebo is composed of the carriers of ESIT12 : arabic gum, sucrose and silicon dioxide mix

Primary outcomes

  1. 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 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.

  2. 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 phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured.

  3. 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 phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.

  4. 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 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.

  5. 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 phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured.

  6. 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 phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.

Sponsors and collaborators

Lead sponsor

Fytexia

Industry

Collaborators

  • Universidad Católica San Antonio de Murcia

Registry information

Official study title

Evaluation of Nutrikinetic and Bioavailability of Phenolic Compounds From ESIT12, a Poplar-type Propolis Dry Extract

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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