Evaluating kinetics and bioavailability of Aronia Melanocarpa extract in healthy young and older adults

Recruiting

• Conditions: farmacokinetiek; absorption; bioavailability; pharmacokinetics

• Registration Number: NL-OMON56259
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The bioavailability and pharmacokinetics of AME will be assessed via frequent<br /><br>blood sampling, urine collection, and faecal sampling, in which AME and<br /><br>metabolite profiles will be quantified. Blood samples will be collected at<br /><br>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,<br /><br>t=24h, t=48h following AME intake. Urine samples will be collected at t=0h, and<br /><br>in 6 different time intervals, i.e. t=0-4h, t=4-8h, t=8-12h, t=12-16h,<br /><br>t=16-24h, and t=24h-48h. Available faecal samples will be collected and<br /><br>combined into one sample until t=48h on a voluntary basis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>