Bioavailability of Aronia Melanocarpa

NCT06306911 | Recruiting DMC

• 1 other identifier: BB-BAM
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability; Kinetics

Outcome Measures

Primary Outcomes (2)

• Aronia metabolites in blood

  Concentrations and quality of Aronia metabolites in blood analysed with LC-MS

  time = 0 hours until t = 48 hours

• Aronia metabolites in urine

  Concentrations and quality of Aronia metabolites in urine analysed with LC-MS

  time = 0 hours until t = 48 hours

Secondary Outcomes (4)

• Aronia metabolites in feces

  time = 0 hours

• length - baseline characteristics

  time = 0 hours

• weight - baseline characteristics

  time = 0 hours

• blood pressure (systolic and diastolic) - baseline characteristics

  time = 0 hours

Study Arms (1)

Aronia Melanocarpa extract

EXPERIMENTAL

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

Dietary Supplement: Aronia Melanocarpa extract

Interventions

Aronia Melanocarpa extract DIETARY_SUPPLEMENT

Aronia Melanocarpa extract (AME) consisting of a mixture of anthocyanins and other polyphenols

Aronia Melanocarpa extract

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• BioActor: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

RECRUITING

Study Officials

• Jogchum Plat, Prof

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne Ahles, Msc

CONTACT

+31437114555; s.ahles@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 12, 2024
• Study Start: March 25, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)