Rice Anthocyanin Bioavailability in Humans

NCT03935022 | Completed

• 1 other identifier: Unimi_DiSAA_01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aims of the project

1. 1.To determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS
2. 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. 3.To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in plasma antioxidant capacity ABTS

  0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours

• Changes in plasma antioxidant capacity DPPH

  0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours

Study Arms (3)

Black rice Venere

EXPERIMENTAL

Healthy volunteers will receive the black rice Venere in a cross-over randomized clinical trial (after 7 days wash-out).

Other: Rice

Black rice Artemide

EXPERIMENTAL

Healthy volunteers will receive the black rice Artemide in a cross-over randomized clinical trial (after 7 days wash-out).

Other: Rice

Complete white rice

SHAM COMPARATOR

Healthy volunteers will receive the complete white rice in a cross-over randomized clinical trial (after 7 days wash-out).

Other: Rice

Interventions

Rice OTHER

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 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.

Black rice Artemide; Black rice Venere; Complete white rice

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy status
• Age: 18-45
• Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed consent.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Marcello Iriti

Milan, MI, 20133, Italy

Location

Related Publications (5)

• Garcia-Conesa MT, Chambers K, Combet E, Pinto P, Garcia-Aloy M, Andres-Lacueva C, de Pascual-Teresa S, Mena P, Konic Ristic A, Hollands WJ, Kroon PA, Rodriguez-Mateos A, Istas G, Kontogiorgis CA, Rai DK, Gibney ER, Morand C, Espin JC, Gonzalez-Sarrias 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):694. doi: 10.3390/ijms19030694.

  PMID: 29495642 BACKGROUND

• 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.

  PMID: 30698008 BACKGROUND

• 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.

  PMID: 30404149 BACKGROUND

• 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.

  PMID: 28858891 BACKGROUND

• 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.

  PMID: 25075608 BACKGROUND

Study Officials

• Marcello Iriti

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 2, 2019
• Study Start: March 6, 2019
• Primary Completion: May 15, 2019
• Study Completion: July 21, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)