Bioavailability of Aronia Melanocarpa

March 11, 2024 updated by: Maastricht University Medical Center

Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults

The main objective of this study is to study the bioavailability and kinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults. During the test day, participants will ingest a drink consisting of Aronia Melanocarpa extract (AME). The bioavailability and kinetics of AME will be assessed via frequent blood sampling, urine collection, and faecal sampling, in which AME and metabolite profiles will be quantified.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18-35 kg/m2
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
  • Stable body weight (weight gain or loss < 3 kg in the past three months)
  • Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study

Exclusion Criteria:

  • Smoking or smoking cessation < 12 months
  • Severe medical conditions, including asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders such as Crohn's disease, colitis
  • Use of dietary supplements or medication affecting the main outcomes of the study (e.g. affecting gut metabolism, blood pressure medication)
  • Use of an investigational product within another biomedical intervention trial within the previous month
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Known pregnancy or lactation
  • Known allergy to study product
  • Difficult venepuncture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aronia Melanocarpa extract
a drink consisting of AME (Aronia Melanocarpa extract) and water.
Dietary supplement: Aronia Melanocarpa extract
Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aronia metabolites in blood
Time Frame: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in blood analysed with LC-MS
time = 0 hours until t = 48 hours
Aronia metabolites in urine
Time Frame: time = 0 hours until t = 48 hours
Concentrations and quality of Aronia metabolites in urine analysed with LC-MS
time = 0 hours until t = 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aronia metabolites in feces
Time Frame: time = 0 hours
Concentrations and quality of Aronia metabolites in feces analysed with LC-MS
time = 0 hours
length - baseline characteristics
Time Frame: time = 0 hours
length
time = 0 hours
weight - baseline characteristics
Time Frame: time = 0 hours
weight
time = 0 hours
blood pressure (systolic and diastolic) - baseline characteristics
Time Frame: time = 0 hours
blood pressure
time = 0 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

BioActor

Investigators

  • Principal Investigator: Jogchum Plat, Prof, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • BB-BAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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