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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Rice Anthocyanin Bioavailability in Humans

Clinicaltrials.gov identifier NCT03935022

Recruitment Status Completed

First Posted May 2, 2019

Last update posted April 3, 2020

Study Description

Brief 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.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Other: Rice
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 20 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Basic Science
  • Official Title: Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake
  • Actual Study Start Date: March 2019
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: July 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Black rice Artemide
Healthy volunteers will receive the black rice Artemide in a cross-over randomized clinical trial (after 7 days wash-out).
Other: Rice
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.
Experimental: Black rice Venere
Healthy volunteers will receive the black rice Venere in a cross-over randomized clinical trial (after 7 days wash-out).
Other: Rice
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.
Sham Comparator: Complete white rice
Healthy volunteers will receive the complete white rice in a cross-over randomized clinical trial (after 7 days wash-out).
Other: Rice
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.
Outcome Measures
  • Primary Outcome Measures: 1. Changes in plasma total anthocyanin detection [ Time Frame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours ]
    Total anthocyanins will be detected via spectrophometric determination; expressed as μg of catechin per mL of plasma
  • 2. Changes in plasma Cyanidin-3-O-glucoside detection [ Time Frame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours ]
    Cyanidin-3-O-glucoside will be detected via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS) in plasma; expressed nM (nano molar) in plasma
  • Secondary Outcome Measures: 1. Changes in plasma antioxidant capacity ABTS [ Time Frame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours ]
    2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS+); the results are expressed as Trolox equivalent antioxidant capacity (TEAC, mmoleq Trolox/mL plasma)
  • 2. Changes in plasma antioxidant capacity DPPH [ Time Frame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours ]
    2,2-diphenyl-1-picrylhydrazyl (DPPH); percentage of inhibition (I%) is calculated as [(ABScontrol 517 nm − ABSsample 517 nm/ABScontrol 517 nm)×100]
Eligibility Criteria
  • Ages Eligible for Study: 20 to 35 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Healthy status

- Age: 18-45

- Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed
consent.

Exclusion Criteria:

- <18 Years; - Pregnancy and lactation; - Systemic disorders; - Dietary supplements intake (vitamins, antioxidants, botanicals, phytochemicals) - Abnormal hematological parameters; - Heavy smoking and alcohol drinking; - High-intensity physical activity.

Contacts and Locations
Contacts
Locations

Italy, MI
Marcello Iriti
Milano

Sponsors and Collaborators

University of Milan

Investigators

Principal Investigator: Marcello Iriti University of Milan

More Information