Bioavailability of Aronia Melanocarpa

Not Applicable

Recruiting

• Conditions: Kinetics; Bioavailability
• Interventions: Dietary Supplement: Aronia Melanocarpa extract

• Registration Number: NCT06306911
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-12
• Study Start: 2024-03-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aronia Melanocarpa extract	Aronia Melanocarpa extract	a drink consisting of AME (Aronia Melanocarpa extract) and water.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands