Rice Anthocyanin Bioavailability in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Aims of the project

        1. To determine the rice anthocyanin content via high-performance liquid
           chromatographycoupled to mass spectrometry, HPLC-MS

        2. To study the oral bioavailability of anthocyanins in healthy volunteers after the intake
           of a serving (80 g) of black rice (Venere and Artemide varieties).

        3. To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric
           determination and high-performance liquid chromatographycoupled to mass spectrometry,
           HPLC-MS.
    

Detailed description: 
      To limit the interindividual variability, The protocol will be designed as a prospective,
      randomized, cross-over pharmacokinetic study on healthy volunteers. Participants will be
      randomly divided into three groups (black rice Venere, black rice Artemide and white
      rice/control) by an allocation software ( http://graphpad.com/quickcalcs/randomise1.cfm )
      which will generate different random sequences of the treatment assignment.

      Subjects will be deprived of anthocyanin-rich food sources 7 days before experimentation
      (wash-out period). Each volunteer will receive a complete list of anthocyanin-rich foods to
      be avoided, including berry fruits (i.e. blueberries, cranberries, raspberries, blackcurrants
      and elderberries), red/violet fruits/vegetables (i.e. grapes, cherries, pomegranates, red
      apples, plums, eggplants, tomatoes and peppers), red wine and other colored products (i.e.
      marmalade, jams and juices containing berries). Breakfast, lunch and dinner will be
      standardized 1 day before the experiment. Each group will randomly receive, during three
      different experimental days, one of the following treatments by different allocation
      sequences:

        1. 80g of black rice Venere (Group A)

        2. 80g of black rice Artemide (Group B)

        3. 80g of white rice (Group C)

      Therefore, each subject will be involved in three experimental days. The three treatments
      will be separated by a 7 day wash-out period.

      After an overnight fast, volunteers will consume the rice serving within 10-15 min,
      immediately after the first basal blood collection at 8:00 a.m. (baseline). Other blood
      withdrawals will be collected after 30 minutes, 1 hour, 2 hours, 3 hours.

      Chemical analyses. The extraction protocols of anthocyanins from body fluids will be
      developed, in order to reach the maximum yield of the analytes from the samples. Plasma
      anthocyanins will be measured by spectrophometric determination and high-performance liquid
      chromatographycoupled to mass spectrometry, HPLC-MS.
    

Intervention name(s): Rice
Intervention type(s): Other
Intervention description(s): Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
80g of black rice Venere (Group A)
80g of black rice Artemide (Group B)
80g of brown rice (Group C) The three treatments will be separated by a 7 day wash-out period. After an overnight fast, volunteers will consume the rice serving within 10-15 min, immediately after the first basal blood collection at 8:00 a.m. (baseline). Other blood withdrawals will be carried out a 0.5, 1.0, 2.0 and 3.0 h after rice administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science