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

Fytexia

Status: Completed

Conditions: Nutrition, Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: ESIT12 4D; Dietary Supplement: ESIT12 D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06062511

ESIT12BAS

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 25 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups, including a placebo group

Verum ESIT12 D

Experimental group

Description:

This arm receives 400 mg of ESIT12 and 150 mg of carriers from ESIT12

Treatment:

Dietary Supplement: ESIT12 D

Verum ESIT12 4D

Experimental group

Description:

This arm receives 1600 mg of ESIT12 and 600 mg of carriers from ESIT12

Treatment:

Dietary Supplement: ESIT12 4D

Placebo

Placebo Comparator group

Description:

This arm receives 550 mg of carriers from ESIT12

Treatment:

Dietary Supplement: Placebo