Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485885
• Other study ID #: BTS1093/17
• Status: Completed
• Start date: November 23, 2017
• Est. completion date: December 12, 2017

Study information

• Verified date: January 2019
• Source: Anklam Extrakt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

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

Locations

Country	Name	City	State
Germany	Nutritional CRO & Study site; BioTeSys GmbH	Esslingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Anklam Extrakt	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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