Rice Anthocyanin Bioavailability in Humans

Healthy Clinical Trial

Official title:

Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935022
• Other study ID #: Unimi_DiSAA_01
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: July 21, 2019

Study information

• Verified date: April 2020
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 21, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Italy	Marcello Iriti	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Ciulu M, Cádiz-Gurrea ML, Segura-Carretero A. Extraction and Analysis of Phenolic Compounds in Rice: A Review. Molecules. 2018 Nov 6;23(11). pii: E2890. doi: 10.3390/molecules23112890. Review. — View 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. Review. — View Citation

García-Conesa MT, Chambers K, Combet E, Pinto P, Garcia-Aloy M, Andrés-Lacueva C, de Pascual-Teresa S, Mena P, Konic Ristic A, Hollands WJ, Kroon PA, Rodríguez-Mateos A, Istas G, Kontogiorgis CA, Rai DK, Gibney ER, Morand C, Espín JC, González-Sarrías A. Meta-Analysis of the Effects of Foods and Derived Products Containing Ellagitannins and Anthocyanins on Cardiometabolic Biomarkers: Analysis of Factors Influencing Variability of the Individual Responses. Int J Mol Sci. 2018 Feb 28;19(3). pii: E694. doi: 10.3390/ijms19030694. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma total anthocyanin detection	Total anthocyanins will be detected via spectrophometric determination; expressed as µg of catechin per mL of plasma	0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Primary	Changes in plasma Cyanidin-3-O-glucoside detection	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	0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Secondary	Changes in plasma antioxidant capacity ABTS	2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS+); the results are expressed as Trolox equivalent antioxidant capacity (TEAC, mmoleq Trolox/mL plasma)	0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Secondary	Changes in plasma antioxidant capacity DPPH	2,2-diphenyl-1-picrylhydrazyl (DPPH); percentage of inhibition (I%) is calculated as [(ABScontrol 517 nm - ABSsample 517 nm/ABScontrol 517 nm)×100]	0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours