Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: Standardized maqui berry extract enriched in anthocyanins

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Esslingen, Baden-Württemberg, Germany, 73728
      • Nutritional CRO & Study site; BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

normal population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Maqui Berry Extract (MBE); To be tested for the extracts bioavailability	Dietary supplement: Standardized maqui berry extract enriched in anthocyanins; Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water; Other Names: Delphinol® / MaquiBright®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]).	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).	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])	Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake

Collaborators and Investigators

• Sponsor: Anklam Extrakt
• Collaborators: BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): December 12, 2017
• Study Completion (Actual): December 12, 2017

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: anthocyanins, maqui berries, bioavailability
• Other Study ID Numbers: BTS1093/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No