Health TrialsbyHealthPanel

Bioavailability of Aronia Melanocarpa

ConditionsBioavailabilityKinetics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMaastricht University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Aronia Melanocarpa extract

    Dietary supplement

    Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Aronia Melanocarpa extractExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aronia metabolites in blood

Concentrations and quality of Aronia metabolites in blood analysed with LC-MS

Time frame
time = 0 hours until t = 48 hours
2

Aronia metabolites in urine

Concentrations and quality of Aronia metabolites in urine analysed with LC-MS

Time frame
time = 0 hours until t = 48 hours

Secondary outcomes

1

Aronia metabolites in feces

Concentrations and quality of Aronia metabolites in feces analysed with LC-MS

Time frame
time = 0 hours
2

length - baseline characteristics

length

Time frame
time = 0 hours
3

weight - baseline characteristics

weight

Time frame
time = 0 hours
4

blood pressure (systolic and diastolic) - baseline characteristics

blood pressure

Time frame
time = 0 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University Medical Center

Lead sponsor

BioActor

Collaborator

Source ClinicalTrials.gov
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