Clinical trial NCT03485885: Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
Official title: Bioavailability of Maqui Berry Extracts (Delphinol® / MaquiBright®) in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioavailability
Keywords: anthocyanins, maqui berries, bioavailability
Lead sponsor: Anklam Extrakt
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2018-04-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: normal population

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
2. Sex: female and male
3. Age: 18- 50 years
4. BMI ≥19 or ≤30 kg/m²
5. Non-smoker
6. Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology

Exclusion Criteria:

Subjects who met one or more of the following criteria are not eligible:

1. Relevant history or presence of any medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, etc.)
2. For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
3. Coffee consumption \>3 cups / day
4. Consumption of more than 5 portions fruits and vegetables per day
5. Blood donation within 1 month prior to study start or during study
6. 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)
7. Vegetarians / vegans
8. Drug-, alcohol- and medication abuses
9. Known HIV-infection
10. Known acute or chronic hepatitis B and C infection
11. Relevant allergy or known hypersensitivity against compounds of the study preparations
12. Known pregnancy, breast feeding or intention to become pregnant during the study
13. Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
14. Anticipating any planned changes in lifestyle for the duration of the study

Primary outcomes:
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).
timeFrame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
measure: 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).
timeFrame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
measure: Ferric reducing ability of plasma (FRAP) measurement in a kinetics, evaluating the change between baseline and selected time points (see below).
timeFrame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake
Secondary outcomes:
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: Nutritional CRO & Study site; BioTeSys GmbH
state: Baden-Württemberg
Study officials:
References: