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

Fytexia10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Nutrition, Healthy

Interventions

ESIT12 DDIETARY_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 4DDIETARY_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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, Spain

Outcomes

Primary Outcomes

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 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-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

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.

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

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.

Data from ClinicalTrials.gov

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