HealthyNCT03935022
Rice Anthocyanin Bioavailability in Humans
A study testing Rice in people with Healthy, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2019to 21 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status
- Age: 18-45
- Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed consent.
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Black rice Venere | Experimental | Healthy volunteers will receive the black rice Venere in a cross-over randomized clinical trial (after 7 days wash-out). Receives: 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). Receives: 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). Receives: Other: Rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma total anthocyanin detection
Total anthocyanins will be detected via spectrophometric determination; expressed as μg of catechin per mL of plasma
Measured: 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
Measured: 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
2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS+); the results are expressed as Trolox equivalent antioxidant capacity (TEAC, mmoleq Trolox/mL plasma)
Measured: 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
2,2-diphenyl-1-picrylhydrazyl (DPPH); percentage of inhibition (I%) is calculated as [(ABScontrol 517 nm - ABSsample 517 nm/ABScontrol 517 nm)×100]
Measured: 0.0 (baseline, before starting the intervention), then after 0.5 hour, 1 hour, 2 hours and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start6 Mar 2019
- Primary completion15 May 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Iriti, University of Milan
- Investigators
- Marcello Iriti, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935022
- Sponsor's protocol ID
- Unimi_DiSAA_01
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29495642Krga 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.
PubMed 30698008Ciulu 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.
PubMed 30404149Dias 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.
PubMed 28858891Van 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.
PubMed 25075608
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthocyanin Bioavailability and Plasma Antioxidant Capacity in Healthy Volunteers After Acute Rice Intake
- ClinicalTrials.gov ID
- NCT03935022
- Acronym / sponsor ID
- Unimi_DiSAA_01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black rice Venere | Experimental | Other: RiceHealthy volunteers will receive the black rice Venere in a cross-over randomized clinical trial (after 7 days wash-out). |
| Black rice Artemide | Experimental | Other: RiceHealthy volunteers will receive the black rice Artemide in a cross-over randomized clinical trial (after 7 days wash-out). |
| Complete white rice | Sham comparator | Other: RiceHealthy volunteers will receive the complete white rice in a cross-over randomized clinical trial (after 7 days wash-out). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy status
- Age: 18-45
- Normal weight (BMI 18.5-24.9) who voluntarily accept to join the study, after informed consent.
Key exclusion criteria (7 listed)
- <18 Years;
- Pregnancy and lactation;
- Systemic disorders;
- Dietary supplements intake (vitamins, antioxidants, botanicals, phytochemicals)
- Abnormal hematological parameters;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiceEach 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. | Other | Black rice Artemide, Black rice Venere, Complete white rice |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 29495642Garcia-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.
- Background: PubMed 30698008Krga 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.
- Background: PubMed 30404149Ciulu 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.
- Background: PubMed 28858891Dias 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.
- Background: PubMed 25075608Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcello Iriti principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice in people with Healthy, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935022, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020; AzTrials last refreshed its copy on 4 Nov 2026.