Actively Recruiting
Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults
Led by Maastricht University Medical Center · Updated on 2024-06-13
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
B
BioActor
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the bioavailability and kinetics of Aronia Melanocarpa extract (AME) in healthy young adults aged 18 to 35 and older adults aged 55 to 75. The study aims to understand how AME, which contains anthocyanins and other polyphenols, is absorbed and processed in the body. This research is conducted by Maastricht University Medical Center and involves healthy volunteers with specific health criteria. Participants will consume a drink made from Aronia Melanocarpa extract and water during a test day. The study focuses on measuring AME and its metabolites over time to assess how the body absorbs and processes the extract. Blood samples, urine, and fecal samples will be collected at various time points from the start of ingestion up to 48 hours afterward to analyze these compounds. During the study, participants will undergo frequent blood draws, urine collection, and fecal sampling to track the presence of Aronia metabolites. Baseline characteristics like length, weight, and blood pressure will also be recorded. The study monitors these outcomes to evaluate the extract's kinetics and bioavailability, with the entire observation period lasting up to 48 hours following supplementation.
CONDITIONS
Brief Title
Bioavailability of Aronia Melanocarpa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI between 18-35 kg/m2
- Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
- Stable body weight with less than 3 kg gain or loss in the past three months
- Willingness to stop blood donation from 8 weeks before the study until 4 weeks after completion
You will not qualify if you...
- Smoking currently or quitting smoking less than 12 months ago
- Severe medical conditions such as asthma, kidney failure, auto-inflammatory diseases, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, gastrointestinal disorders like Crohn's disease or colitis
- Use of dietary supplements or medications affecting gut metabolism or blood pressure
- Participation in another biomedical trial with investigational products within the last month
- Drug abuse
- More than 3 alcoholic drinks per day
- Known pregnancy or breastfeeding
- Allergy to the study product
- Difficult venepuncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants consume a drink consisting of Aronia Melanocarpa extract and water to evaluate its bioavailability.
Several visits within 48 hours for blood, urine, and feces sample collections
Trial Site Locations
Total: 1 location
1
Maastricht University
Maastricht, Netherlands
Actively Recruiting
Research Team
S
Sanne Ahles, Msc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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