Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Bioavailability of Maqui Berry Extracts (Delphinol® / MaquiBright®) in Healthy Subjects

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: Standardized maqui berry extract enriched in anthocyanins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanins, maqui berries, bioavailability