Status:
COMPLETED
Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects
Lead Sponsor:
Anklam Extrakt
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Bioavailability
Eligibility:
All Genders
18-50 years
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 delphinidin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03485885
Start Date
November 23 2017
End Date
December 12 2017
Last Update
January 10 2019
Active Locations (1)
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1
Nutritional CRO & Study site; BioTeSys GmbH
Esslingen am Neckar, Baden-Wurttemberg, Germany, 73728