Bioavailability, Kinetics
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAronia Melanocarpa extract
Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols
Sponsors
BioActor
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aronia metabolites in blood | time = 0 hours until t = 48 hours | Concentrations and quality of Aronia metabolites in blood analysed with LC-MS |
| Aronia metabolites in urine | time = 0 hours until t = 48 hours | Concentrations and quality of Aronia metabolites in urine analysed with LC-MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aronia metabolites in feces | time = 0 hours | Concentrations and quality of Aronia metabolites in feces analysed with LC-MS |
| length - baseline characteristics | time = 0 hours | length |
| weight - baseline characteristics | time = 0 hours | weight |
| blood pressure (systolic and diastolic) - baseline characteristics | time = 0 hours | blood pressure |
Countries
Netherlands
Contacts
Primary ContactSanne Ahles, Msc
Outcome results
None listed