Rice Anthocyanin Bioavailability in Humans
Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake
Aims of the project
- To determine the rice anthocyanin content via high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS
- 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).
- To determine the plasma biokinetics parameters of rice anthocyanins via spectrophometric determination and high-performance liquid chromatographycoupled to mass spectrometry, HPLC-MS.
Study Overview
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:
- 80g of black rice Venere (Group A)
- 80g of black rice Artemide (Group B)
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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MI
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Milano, MI, Italy, 20133
- Marcello Iriti
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Black rice Venere
Healthy volunteers will receive the black rice Venere in a cross-over randomized clinical trial (after 7 days wash-out).
|
Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
|
|
EXPERIMENTAL: Black rice Artemide
Healthy volunteers will receive the black rice Artemide in a cross-over randomized clinical trial (after 7 days wash-out).
|
Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
|
|
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).
|
Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
|
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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
|
0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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]
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0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcello Iriti, University of Milan
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Unimi_DiSAA_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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