- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645394
Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study
Bioavailability of Anthocyanins From Aronia Extract
Study Overview
Status
Conditions
Detailed Description
Methods for possible intervention The trial will be executed in accordance with the guidelines of the declaration of Helsinki and will be approved by The Danish Ethical Committee (1-10-72-57-20). The study is designed as a randomized acute-crossover study repeated on 4 separate days. All participants will be screened, and written consent must be obtained before the initiation of the study. Prior to the first intervention day, participants will be randomized to the order of the intervention; placebo, 1/6 mg or 1/1 fermented aronia extract or non-fermented aronia extract. In order to prevent any cross contamination between intervention days, no less than 3 washout days must pass between intervention days. Participants must be fasting for at least 8 hours with only water allowed.
Participants Participants will be recruited by advertisements as well as social media. Potential candidates will afterwards be referred to the head of the study who will orally explain the study. Provided interest from candidate, a written consent must be obtained. Participants will have the right to end their participation at any given point.
Intervention day and blood collections On intervention days, participants arrive fasting (water allowed since midnight). The intervention will be randomized as to which of the four interventions the participants are going to consume on the day. All participants will consume each intervention of either placebo, 1/6 or 1/1 dose fermented aronia extract or 1/1 dose from non-fermented aronia extract. 15 mins prior to consuming the intervention, a blood sample will be collected. Another sample will be collected at time 0 h, after which time the aronia extract along with 200 mL water must be consumed. Then, at time 60, 120, 240 and 360 min, blood must be collected also. At least 3 washout days must pass between intervention to ensure no cross contamination.
Biochemical analysis Following a successful collection of 6 blood samples over the course of 360 mins on intervention day, the blood from each participant will be stored at -80°C until analysis. The blood samples will be coded in an anonymous way to ensure that blood sample cannot be connected to participant to ensure anonymity. The analysis can be carried out by means of high-pressure liquid chromatography (HPLC) or an equivalent method. The blood samples must be evaluated for their possible anthocyanin content as well as their phenolic compound content.
Statistical analysis Primary outcome is area under the curve (total and incremental) for the response curves of anthocyanins.
To determine differences between groups, ANOVA test will be carried out. Data are considered significant if p < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Danmark
-
Aarhus N, Danmark, Denmark, 8200
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- man between ≥20 ≤75 years of age
Exclusion Criteria:
- Daily usage of medicine, alcohol- or substance abuse
- BMI ≥30
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
The participants are receiving 1 dose of each in the stated order.
|
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
|
Active Comparator: Fermented aronia high dose
The participants are receiving 1 dose of each in the stated order.
|
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
|
Active Comparator: Fermented aronia low dose
The participants are receiving 1 dose of each in the stated order.
|
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
|
Active Comparator: Aronia
The participants are receiving 1 dose of each in the stated order.
|
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
Other Names:
Administered once (acute study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
area under the curve for anthocyanin blood concentration
Time Frame: -15, 0, 60, 120, 240, 360 minutes
|
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
|
-15, 0, 60, 120, 240, 360 minutes
|
incremental area under the curve for anthocyanin blood concentration
Time Frame: -15, 0, 60, 120, 240, 360 minutes
|
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
|
-15, 0, 60, 120, 240, 360 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of polyphenols in the blood
Time Frame: -15, 0, 60, 120, 240, 360 minutes
|
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
|
-15, 0, 60, 120, 240, 360 minutes
|
Antioxidant activity in the blood
Time Frame: -15, 0, 60, 120, 240, 360 minutes
|
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
|
-15, 0, 60, 120, 240, 360 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1-10-72-57-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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