Clinical trial NCT03935022: Rice Anthocyanin Bioavailability in Humans
Official title: Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in plasma total anthocyanin detection
timeFrame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
measure: Changes in plasma Cyanidin-3-O-glucoside detection
timeFrame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Secondary outcomes:
measure: Changes in plasma antioxidant capacity ABTS
timeFrame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
measure: Changes in plasma antioxidant capacity DPPH
timeFrame: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Marcello Iriti
state: MI
Study officials:
affiliation: University of Milan
name: Marcello Iriti
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Krga I, Milenkovic D. Anthocyanins: From Sources and Bioavailability to Cardiovascular-Health Benefits and Molecular Mechanisms of Action. J Agric Food Chem. 2019 Feb 20;67(7):1771-1783. doi: 10.1021/acs.jafc.8b06737. Epub 2019 Feb 8.
citation: Ciulu M, Cadiz-Gurrea ML, Segura-Carretero A. Extraction and Analysis of Phenolic Compounds in Rice: A Review. Molecules. 2018 Nov 6;23(11):2890. doi: 10.3390/molecules23112890.
citation: Dias ALS, Pachikian B, Larondelle Y, Quetin-Leclercq J. Recent advances on bioactivities of black rice. Curr Opin Clin Nutr Metab Care. 2017 Nov;20(6):470-476. doi: 10.1097/MCO.0000000000000417.
citation: Van Hung P. Phenolic Compounds of Cereals and Their Antioxidant Capacity. Crit Rev Food Sci Nutr. 2016;56(1):25-35. doi: 10.1080/10408398.2012.708909.