Bioavailability of Aronia Melanocarpa

Bioavailability Clinical Trial

Official title:

Evaluating Kinetics and Bioavailability of Aronia Melanocarpa Extract in Healthy Young and Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306911
• Other study ID #: BB-BAM
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: Maastricht University Medical Center
• Contact: Sanne Ahles, Msc
• Phone: +31437114555
• Email: s.ahles[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability
• Kinetics

Intervention

Dietary Supplement:
• Aronia Melanocarpa extract
Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	BioActor

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aronia metabolites in blood	Concentrations and quality of Aronia metabolites in blood analysed with LC-MS	time = 0 hours until t = 48 hours
Primary	Aronia metabolites in urine	Concentrations and quality of Aronia metabolites in urine analysed with LC-MS	time = 0 hours until t = 48 hours
Secondary	Aronia metabolites in feces	Concentrations and quality of Aronia metabolites in feces analysed with LC-MS	time = 0 hours
Secondary	length - baseline characteristics	length	time = 0 hours
Secondary	weight - baseline characteristics	weight	time = 0 hours
Secondary	blood pressure (systolic and diastolic) - baseline characteristics	blood pressure	time = 0 hours