Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

NCT ID: NCT03485885

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-23
• Study Completion Date: 2017-12-12

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Maqui Berry Extract (MBE)

To be tested for the extracts bioavailability

Standardized maqui berry extract enriched in anthocyanins

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Delphinol® / MaquiBright®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioTeSys GmbH

OTHER

Sponsor Role: collaborator

Anklam Extrakt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nutritional CRO & Study site; BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

BTS1093/17

Identifier Type: -

Identifier Source: org_study_id