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

NCT06062511 | Completed

• 1 other identifier: ESIT12BAS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline (pre-ingestion) to 24 hour post-ingestion

• Change in plasma maximal concentration (Cmax) 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 maximal concentration in nmol/L is measured.

  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.

  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.

  Baseline (pre-ingestion) to 48 hour post-ingestion

• Change in urine maximal concentration (Cmax) 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 maximal concentration in nmol/L is measured.

  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

  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.

  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

Study Arms (3)

Verum ESIT12 D

EXPERIMENTAL

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

Dietary Supplement: ESIT12 D

Verum ESIT12 4D

EXPERIMENTAL

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

Dietary Supplement: ESIT12 4D

Placebo

PLACEBO COMPARATOR

This arm receives 550 mg of carriers from ESIT12

Dietary Supplement: Placebo

Interventions

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

Verum ESIT12 D

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

Verum ESIT12 4D

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 25 Years - 69 Years
• Gender Eligibility Details: Male and female with 40% min. and 60% max. of each sex.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fytexia: lead
• Universidad Católica San Antonio de Murcia: collaborator

Study Sites (1)

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

Study Officials

• Pedro E. Alcaraz, PhD

  UCAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: October 2, 2023
• Study Start: July 22, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)