Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

NCT03485885 | Completed

• 1 other identifier: BTS1093/17
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

anthocyanins, maqui berries, bioavailability

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Maqui Berry Extract (MBE)

To be tested for the extracts bioavailability

Dietary Supplement: Standardized maqui berry extract enriched in anthocyanins

Interventions

Standardized maqui berry extract enriched in anthocyanins DIETARY_SUPPLEMENT

Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water

Also known as: Delphinol® / MaquiBright®

Maqui Berry Extract (MBE)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

normal population

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Anklam Extrakt: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

Nutritional CRO & Study site; BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples

MeSH Terms

Interventions

Anthocyanins; Delphinol

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 3, 2018
• Study Start: November 23, 2017
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)