The main objective of this study is to study the bioavailability and pharmacokinetics of acute Aronia Melanocarpa supplementation in healthy young (18-35 years) and older adults (55-75 years) adults.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
farmacokinetiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The bioavailability and pharmacokinetics of AME will be assessed via frequent
blood sampling, urine collection, and faecal sampling, in which AME and
metabolite profiles will be quantified. Blood samples will be collected at
t=0h, t=0.5h, t=1h, t=1.5h t=2h, t=2.5h, t=3h, t=4h, t=6h, t=8h, t=10h, t=12h,
t=24h, t=48h following AME intake. Urine samples will be collected at t=0h, and
in 6 different time intervals, i.e. t=0-4h, t=4-8h, t=8-12h, t=12-16h,
t=16-24h, and t=24h-48h. Available faecal samples will be collected and
combined into one sample until t=48h on a voluntary basis.
Secondary outcome
n.a.
Background summary
Anthocyanins are a subgroup of flavonoids (polyphenolic compounds) that are
mainly found in berries. Anthocyanins and their associated metabolites, such as
cyanidin-3-glycosides, are generally recognized for their health benefits. For
example, they cross the blood-brain barrier, where they can act as promising
agents for the prevention of neurodegenerative diseases. Moreover, effects on
vascular function and consequently cardiovascular risk reduction have also been
described. A high concentration of anthocyanins is found in Aronia Melanocarpa
(AME). As the dietary intake of anthocyanins in the population is considered
low, supplementation is considered an important approach to improve plasma
levels. Since ageing changes physiological processes like gastrointestinal
tract motility, liver and renal function, metabolism, absorption, and enzyme
activity, anthocyanin metabolism and bioavailability might differ between
younger and older age groups. Currently, bioavailability studies where
metabolites in different age groups are compared side by side are lacking. This
knowledge is relevant since the necessary dietary intake to reach a certain
threshold concentration in the circulation could be different in younger and
older subjects.
Study objective
The main objective of this study is to study the bioavailability and
pharmacokinetics of acute Aronia Melanocarpa supplementation in healthy young
(18-35 years) and older adults (55-75 years) adults.
Study design
The present study is a pharmacokinetic study, carried out in two age groups.
Intervention
During the test day, participants will ingest a drink consisting of 65 mg AME
(16 mg anthocyanins), and 200 ml water.
Study burden and risks
The participants have to stay at the research facility for 12 hours. During the
study, blood samples will be collected 14 times using a cannula, which may
cause bruising or hematoma. Furthermore, participants will provide urine and
faecal samples for 48 hours in total. From 72 hours before the visit,
participants must adhere to specific dietary restrictions. The participants
will not benefit directly from participation. The AME dose has already been
used in previous studies, with no side effects.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• Men and women, aged between 18-35 years, or between 55-75 years old
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06306911 |
| CCMO | NL85015.068.23 |