BioavailabilityNCT04645394
Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study
A study testing Aronia melanocarpa, Fermented Aronia Melanocarpa high dose and Fermented Aronia Melanocarpa low dose in people with Bioavailability, run by University of Aarhus at 1 site in Denmark.
Trial summary
In a quadruple cross-over design, 8 healthy men will receive 3 different formulations of Aronia extract as well as placebo (placebo, aronia, and fermented aronia in 1/6 and 1/1 concentration). The intervention will be given on four separate days at least three days apart. Read more about this study
- Who is it for?
- Ages 20 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Aronia melanocarpa, Fermented Aronia Melanocarpa high dose and Fermented Aronia Melanocarpa low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Nov 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- man between ≥20 ≤75 years of age
Who cannot join
- Daily usage of medicine, alcohol- or substance abuse
- BMI ≥30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Anthocyanins From Aronia Extract
In a quadruple cross-over design, 8 healthy men will receive 3 different formulations of Aronia extract as well as placebo (placebo, aronia, and fermented aronia in 1/6 and 1/1 concentration). The intervention will be given on four separate days at least three days apart. Before consumption, 2 fasting blood samples will be taken. Blood will also be sampled at 60, 120, 240, and 360 minutes post consumption. The blood samples will be analyzed for polyphenolic content with a special focus on anthocyanins.
Read the 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.
- Conditions
- Bioavailability
- Being tested
- Aronia melanocarpa, Fermented Aronia Melanocarpa high dose, Fermented Aronia Melanocarpa low dose, Placebo
- Keywords
- bioavailability, Aronia melanocarpa, polyphenols, anthocyanins, healthy, men, uptake
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aronia melanocarpaDietary supplement
Also called Chokeberry
Administered once (acute study)
Fermented Aronia Melanocarpa high doseDietary supplement
Also called Chokeberry
Administered once (acute study)
Fermented Aronia Melanocarpa low doseDietary supplement
Also called Chokeberry
Administered once (acute study)
PlaceboDietary supplement
Administered once (acute study)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The participants are receiving 1 dose of each in the stated order. Receives: Dietary Supplement: Aronia melanocarpa; Dietary Supplement: Fermented Aronia Melanocarpa high dose; Dietary Supplement: Fermented Aronia Melanocarpa low dose; Dietary Supplement: Placebo |
| Fermented aronia high dose | Active comparator | The participants are receiving 1 dose of each in the stated order. Receives: Dietary Supplement: Aronia melanocarpa; Dietary Supplement: Fermented Aronia Melanocarpa high dose; Dietary Supplement: Fermented Aronia Melanocarpa low dose; Dietary Supplement: Placebo |
| Fermented aronia low dose | Active comparator | The participants are receiving 1 dose of each in the stated order. Receives: Dietary Supplement: Aronia melanocarpa; Dietary Supplement: Fermented Aronia Melanocarpa high dose; Dietary Supplement: Fermented Aronia Melanocarpa low dose; Dietary Supplement: Placebo |
| Aronia | Active comparator | The participants are receiving 1 dose of each in the stated order. Receives: Dietary Supplement: Aronia melanocarpa; Dietary Supplement: Fermented Aronia Melanocarpa high dose; Dietary Supplement: Fermented Aronia Melanocarpa low dose; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve for anthocyanin blood concentration
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
Measured: -15, 0, 60, 120, 240, 360 minutes
incremental area under the curve for anthocyanin blood concentration
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
Measured: -15, 0, 60, 120, 240, 360 minutes
Secondary outcomes (2)
Concentration of polyphenols in the blood
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
Measured: -15, 0, 60, 120, 240, 360 minutes
Antioxidant activity in the blood
Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption
Measured: -15, 0, 60, 120, 240, 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start23 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute 4-arm crossover intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645394
- Sponsor's protocol ID
- 1-10-72-57-20
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Anthocyanins From Aronia Extract
- ClinicalTrials.gov ID
- NCT04645394
- Acronym / sponsor ID
- 1-10-72-57-20
- Conditions
- Bioavailability
- Keywords
- bioavailability, Aronia melanocarpa, polyphenols, anthocyanins, healthy, men, uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a quadruple cross-over design, 8 healthy men will receive 3 different formulations of Aronia extract as well as placebo (placebo, aronia, and fermented aronia in 1/6 and 1/1 concentration). The intervention will be given on four separate days at least three days apart. Before consumption, 2 fasting blood samples will be taken. Blood will also be sampled at 60, 120, 240, and 360 minutes post consumption. The blood samples will be analyzed for polyphenolic content with a special focus on anthocyanins.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Acute 4-arm crossover intervention.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Aronia melanocarpa, Dietary Supplement: Fermented Aronia Melanocarpa high dose, Dietary Supplement: Fermented Aronia Melanocarpa low dose, Dietary Supplement: PlaceboThe participants are receiving 1 dose of each in the stated order. |
| Fermented aronia high dose | Active comparator | Dietary Supplement: Aronia melanocarpa, Dietary Supplement: Fermented Aronia Melanocarpa high dose, Dietary Supplement: Fermented Aronia Melanocarpa low dose, Dietary Supplement: PlaceboThe participants are receiving 1 dose of each in the stated order. |
| Fermented aronia low dose | Active comparator | Dietary Supplement: Aronia melanocarpa, Dietary Supplement: Fermented Aronia Melanocarpa high dose, Dietary Supplement: Fermented Aronia Melanocarpa low dose, Dietary Supplement: PlaceboThe participants are receiving 1 dose of each in the stated order. |
| Aronia | Active comparator | Dietary Supplement: Aronia melanocarpa, Dietary Supplement: Fermented Aronia Melanocarpa high dose, Dietary Supplement: Fermented Aronia Melanocarpa low dose, Dietary Supplement: PlaceboThe participants are receiving 1 dose of each in the stated order. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- man between ≥20 ≤75 years of age
Key exclusion criteria (2 listed)
- Daily usage of medicine, alcohol- or substance abuse
- BMI ≥30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aronia melanocarpaAlso: ChokeberryAdministered once (acute study) | Dietary supplement | Aronia, Fermented aronia high dose, Fermented aronia low dose, Placebo |
| Fermented Aronia Melanocarpa high doseAlso: ChokeberryAdministered once (acute study) | Dietary supplement | Aronia, Fermented aronia high dose, Fermented aronia low dose, Placebo |
| Fermented Aronia Melanocarpa low doseAlso: ChokeberryAdministered once (acute study) | Dietary supplement | Aronia, Fermented aronia high dose, Fermented aronia low dose, Placebo |
| PlaceboAdministered once (acute study) | Dietary supplement | Aronia, Fermented aronia high dose, Fermented aronia low dose, Placebo |
Primary outcome
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
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
2 secondary outcomes
Concentration of polyphenols in the blood
Time frame: -15, 0, 60, 120, 240, 360 minutes
Antioxidant activity in the blood
Time frame: -15, 0, 60, 120, 240, 360 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aronia melanocarpa, Fermented Aronia Melanocarpa high dose and Fermented Aronia Melanocarpa low dose in people with Bioavailability, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve for anthocyanin blood concentration (time frame: -15, 0, 60, 120, 240, 360 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.