BioavailabilityNCT03485885
Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
An observational study of Bioavailability, run by Anklam Extrakt at 1 site in Germany.
Trial summary
The aim of the present study is to describe the bioavailability for the proprietary standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in particular delphinidins. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Standardized maqui berry extract enriched in anthocyanins
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 23 Nov 2017to 12 Dec 2017
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: normal population
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female and male
- Age: 18- 50 years
- BMI ≥19 or ≤30 kg/m²
- Non-smoker
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Who cannot join
- Subjects who met one or more of the following criteria are not eligible:
- Relevant history or presence of any medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, etc.)
- For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Coffee consumption >3 cups / day
- Consumption of more than 5 portions fruits and vegetables per day
- Blood donation within 1 month prior to study start or during study
Show all 15Show fewer
- Regular intake of drugs or supplements possibly interfering with this study (e.g. Vitamin C, E, OPC etc.) within 2 weeks prior to study start or during study (Vitamin D with highest dosage of 1000 I.E. per day will be allowed)
- Vegetarians / vegans
- Drug-, alcohol- and medication abuses
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Relevant allergy or known hypersensitivity against compounds of the study preparations
- Known pregnancy, breast feeding or intention to become pregnant during the study
- Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- Anticipating any planned changes in lifestyle for the duration of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Nutritional CRO & Study site; BioTeSys GmbH
Esslingen am Neckar, Baden-Wurttemberg, 73728
About this study
Official title: Bioavailability of Maqui Berry Extracts (Delphinol® / MaquiBright®) in Healthy Subjects
The aim of the present study is to describe the bioavailability for the proprietary standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in particular delphinidins. The analyses are based on two selected key substances namely delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.
The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg standardized maqui berry extract in capsules) in 12 healthy subjects.
- Conditions
- Bioavailability
- Being tested
- Standardized maqui berry extract enriched in anthocyanins
- Keywords
- anthocyanins, maqui berries, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized maqui berry extract enriched in anthocyaninsDietary supplement
Also called Delphinol® / MaquiBright®
Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water
| Study group | Role | What they receive |
|---|---|---|
| Maqui Berry Extract (MBE) | To be tested for the extracts bioavailability Receives: Dietary Supplement: Standardized maqui berry extract enriched in anthocyanins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of two specific maqui berry anthocyanins: namely Delphinidin-3-O-glucoside and Cyanidin-3-O-sambubioside in a kinetics, evaluating the change between baseline and selected time points (see below).
Specific anthocyanins related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS (unit [nmol/L]).
Measured: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Quantification of two specific maqui berry anthocyanin derived metabolites: namely gallic acid and protocatechuic acid in a kinetics, evaluating the change between baseline and selected time points (see below).
Specific anthocyanin derived metabolites related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS. Results will most probably be assessed as "AUC" (area under the curve).
Measured: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Ferric reducing ability of plasma (FRAP) measurement in a kinetics, evaluating the change between baseline and selected time points (see below).
The FRAP assay was performed to assess the "antioxidant power" / "antioxidant capacity" of the plasma after intake of maqui berry extract (Delphinol® / MaquiBright®). Method: photometric / absorption maximum at 593 nm (unit [µmol/l])
Measured: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start23 Nov 2017
- Primary completion12 Dec 2017
- Study completion12 Dec 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anklam Extrakt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485885
- Sponsor's protocol ID
- BTS1093/17
- Status last verified
- Jan 2019
- First submitted
- 19 Mar 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Maqui Berry Extracts (Delphinol® / MaquiBright®) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03485885
- Acronym / sponsor ID
- BTS1093/17
- Conditions
- Bioavailability
- Keywords
- anthocyanins, maqui berries, bioavailability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Anklam ExtraktIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 3 Apr 2018 (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.
The aim of the present study is to describe the bioavailability for the proprietary standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in particular delphinidins. The analyses are based on two selected key substances namely delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.
The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg standardized maqui berry extract in capsules) in 12 healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maqui Berry Extract (MBE) | – | Dietary Supplement: Standardized maqui berry extract enriched in anthocyaninsTo be tested for the extracts bioavailability |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- normal population
Key inclusion criteria (6 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female and male
- Age: 18- 50 years
- BMI ≥19 or ≤30 kg/m²
- Non-smoker
Key exclusion criteria (15 listed)
- Relevant history or presence of any medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, etc.)
- For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Coffee consumption >3 cups / day
- Consumption of more than 5 portions fruits and vegetables per day
- Blood donation within 1 month prior to study start or during study
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 |
|---|---|---|
| Standardized maqui berry extract enriched in anthocyaninsAlso: Delphinol® / MaquiBright®Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water | Dietary supplement | Maqui Berry Extract (MBE) |
Primary outcome
Quantification of two specific maqui berry anthocyanins: namely Delphinidin-3-O-glucoside and Cyanidin-3-O-sambubioside in a kinetics, evaluating the change between baseline and selected time points (see below).
Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Specific anthocyanins related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS (unit [nmol/L]).
Quantification of two specific maqui berry anthocyanin derived metabolites: namely gallic acid and protocatechuic acid in a kinetics, evaluating the change between baseline and selected time points (see below).
Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Specific anthocyanin derived metabolites related to maqui berry extract (Delphinol® / MaquiBright®) were measured in plasma samples of healthy subjects and assessed as change to baseline. Method: LC-MS/MS. Results will most probably be assessed as "AUC" (area under the curve).
Ferric reducing ability of plasma (FRAP) measurement in a kinetics, evaluating the change between baseline and selected time points (see below).
Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
The FRAP assay was performed to assess the "antioxidant power" / "antioxidant capacity" of the plasma after intake of maqui berry extract (Delphinol® / MaquiBright®). Method: photometric / absorption maximum at 593 nm (unit [µmol/l])
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 10 Jan 2019.
- Individual participant dataSharing planned: No
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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?
An observational study of Bioavailability, run by Anklam Extrakt at 1 site in Germany.
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 6 inclusion and 15 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 10 Jan 2019. 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 Germany. 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. 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?
Quantification of two specific maqui berry anthocyanins: namely Delphinidin-3-O-glucoside and Cyanidin-3-O-sambubioside in a kinetics, evaluating the change between baseline and selected time points (see below). (time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake). The study lists 3 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 10 Jan 2019.