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

NCT ID: NCT06062511

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-22

Study Completion Date

2023-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum ESIT12 D

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

Group Type EXPERIMENTAL

ESIT12 D

Intervention Type 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

Verum ESIT12 4D

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

Group Type EXPERIMENTAL

ESIT12 4D

Intervention Type 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

This arm receives 550 mg of carriers from ESIT12

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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ESIT12 D

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

Intervention Type DIETARY_SUPPLEMENT

ESIT12 4D

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role collaborator

Fytexia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pedro E. Alcaraz, PhD

Role: PRINCIPAL_INVESTIGATOR

UCAM

Locations

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Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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ESIT12BAS

Identifier Type: -

Identifier Source: org_study_id