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Completed

NCT Number: NCT03485885

Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

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.

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Key information

Conditions

Bioavailability

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nutritional CRO & Study site; BioTeSys GmbH

Esslingen am Neckar, Baden-Wurttemberg, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Delphinol® / MaquiBright®

Primary outcomes

  1. 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).

    Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake

    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]).

  2. 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).

    Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake

    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).

  3. Ferric reducing ability of plasma (FRAP) measurement in a kinetics, evaluating the change between baseline and selected time points (see below).

    Time frame: Kinetics: baseline to 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours after intake

    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])

Sponsors and collaborators

Lead sponsor

Anklam Extrakt

Industry

Collaborators

  • BioTeSys GmbH

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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