Bioavailability of Anthocyanins From Aronia Extract in Healthy Men - a Pilot Study
Condition: Bioavailability
Study type: Interventional

Summary: 
      In a quadruple cross-over design, 8 healthy men will receive 3 different formulations of
      Aronia extract as well as placebo (placebo, aronia, and fermented aronia in 1/6 and 1/1
      concentration). The intervention will be given on four separate days at least three days
      apart. Before consumption, 2 fasting blood samples will be taken. Blood will also be sampled
      at 60, 120, 240, and 360 minutes post consumption. The blood samples will be analyzed for
      polyphenolic content with a special focus on anthocyanins.
    

Detailed description: 
      Methods for possible intervention The trial will be executed in accordance with the
      guidelines of the declaration of Helsinki and will be approved by The Danish Ethical
      Committee (1-10-72-57-20). The study is designed as a randomized acute-crossover study
      repeated on 4 separate days. All participants will be screened, and written consent must be
      obtained before the initiation of the study. Prior to the first intervention day,
      participants will be randomized to the order of the intervention; placebo, 1/6 mg or 1/1
      fermented aronia extract or non-fermented aronia extract. In order to prevent any cross
      contamination between intervention days, no less than 3 washout days must pass between
      intervention days. Participants must be fasting for at least 8 hours with only water allowed.

      Participants Participants will be recruited by advertisements as well as social media.
      Potential candidates will afterwards be referred to the head of the study who will orally
      explain the study. Provided interest from candidate, a written consent must be obtained.
      Participants will have the right to end their participation at any given point.

      Intervention day and blood collections On intervention days, participants arrive fasting
      (water allowed since midnight). The intervention will be randomized as to which of the four
      interventions the participants are going to consume on the day. All participants will consume
      each intervention of either placebo, 1/6 or 1/1 dose fermented aronia extract or 1/1 dose
      from non-fermented aronia extract. 15 mins prior to consuming the intervention, a blood
      sample will be collected. Another sample will be collected at time 0 h, after which time the
      aronia extract along with 200 mL water must be consumed. Then, at time 60, 120, 240 and 360
      min, blood must be collected also. At least 3 washout days must pass between intervention to
      ensure no cross contamination.

      Biochemical analysis Following a successful collection of 6 blood samples over the course of
      360 mins on intervention day, the blood from each participant will be stored at -80°C until
      analysis. The blood samples will be coded in an anonymous way to ensure that blood sample
      cannot be connected to participant to ensure anonymity. The analysis can be carried out by
      means of high-pressure liquid chromatography (HPLC) or an equivalent method. The blood
      samples must be evaluated for their possible anthocyanin content as well as their phenolic
      compound content.

      Statistical analysis Primary outcome is area under the curve (total and incremental) for the
      response curves of anthocyanins.

      To determine differences between groups, ANOVA test will be carried out. Data are considered
      significant if p < 0.05.
    

Intervention name(s): Aronia melanocarpa; Fermented Aronia Melanocarpa high dose; Fermented Aronia Melanocarpa low dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Administered once (acute study); Administered once (acute study); Administered once (acute study); Administered once (acute study)
Other intervention name(s): Chokeberry; Chokeberry; Chokeberry
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Acute 4-arm crossover intervention.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bioavailability; Aronia melanocarpa; polyphenols; anthocyanins; healthy; men; uptake