Older AdultsRICENCT06583785
Black Rice Consumption on Cognitive Function, Inflammation and Microvascular Function in Older Adults
A study testing Black rice (Intervention) in people with Older Adults, run by University of Reading at 2 sites in United Kingdom.
Trial summary
Cognitive (brain) function, especially memory, gradually declines during ageing, which may in part be caused by an increase in systemic inflammation as well as a reduction in vascular functions and cerebral blood flow. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Black rice (Intervention)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Dec 2023to 31 Dec 2024
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50-80 years
- General healthy status
- Body Mass Index (BMI)18.5-35 kg/m2
Who cannot join
- Taking anti-inflammatory drugs (e.g., aspirin, warfarin, ibuprofen)
- Having sign of infections or acute inflammation (e.g., fever, chills, sore throat, nasal congestion, moderate-severe pain, swelling-redness)
- Received antibiotics within the past 3 months
- Taking dietary supplements (e.g., vitamins, minerals) at high doses (e.g., more than 200% of the UK's reference nutrient intakes)
- Taking hormone replacement therapy, if you are menopausal
- Had major surgery (head, heart, chest, abdomen) within the past 6 months.
Show all 17Show fewer
- Having plan to start to a restricted diet/ changing dietary pattern or lose weight.
- Diagnosed with neurodegenerative diseases (e.g., Dementia, Alzheimer's, Parkinson's, current stroke)
- Diagnosed with psychotic disorders (e.g., schizophrenia, bipolar depression, eating disorder)
- Diagnosed with cardiovascular disease, diabetes, hyperlipidemia, hypertension (blood pressure>140/90 mmHg), active cancer, liver, or kidney diseases.
- Taking medication to lower blood fats (e.g., statins, fibrates) or to stabilise blood glucose (e.g., acarbose, metformin or sulfonylureas) or lower blood pressure.
- Unable to complete the cognitive function tasks for any reason (i.e., visual impairments, hearing loss)
- If you have a peacemaker
- If you have bleeding disorders or blood related diseases (anaemia, thalassemia, thrombosis, embolism)
- Heavy smoker
- Heavy alcohol drinking (> 14 units/week) or a history of alcohol/substance abuse
- Allergies, hypersensitivity, or food intolerances (rice, eggs, soy sauce, vegetable oil)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Hugh Sinclair Unit of Human Nutrition
Reading, UK, RG2 6AP
Chusana Mekhora, 07824422127, c.mekhora@pgr.reading.ac.uk
- Recruiting
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, RG2 6AP
Jeremy Spencer, PhD, j.p.e.spencer@reading.ac.uk
About this study
Official title: Impact of Anthocyanin-Rich Black Rice Consumption on Cognitive Function, Inflammation and Micro-vascular Function in Older Adults
Cognitive (brain) function, especially memory, gradually declines during ageing, which may in part be caused by an increase in systemic inflammation as well as a reduction in vascular functions and cerebral blood flow. Blood inflammatory mediators such as c-reactive protein (CRP) and interleukin-6 (IL-6) found to be significantly higher among people over 65 years compared to younger age groups.
Anthocyanins is water-soluble compounds giving blue, purple and red colours in fruits and vegetables. Anthocyanins have been demonstrated to improve cognitive function, inhibit inflammation, and protect cardiovascular health. Black rice contains high amounts of anthocyanins mainly cyanidin 3-glucoside and peonidin 3-glucoside as well as various nutritional compounds such as carbohydrate, vitamin B, vitamin E and fibre. Previous studies reported health benefits of black rice, including anti-inflammation, antioxidative stress, anti-diabetes, and improved cognitive function. However, the effect of black rice consumption on cognitive function related to inflammation has not been studied in humans.
Read more
Therefore, this study aims evaluate the acute \& short-term effects of black rice consumption on the cognitive function, inflammation, and vascular function in older adults aged 50-80 years.
The primary and secondary research questions of this study will address:
- Do the acute and short-term anthocyanin-rich black rice intakes improve cognitive function in older adults aged 50-80 years?
- Do the acute and short-term anthocyanin-rich black rice intakes modulate inflammatory status and microvascular function in older adults aged 50-80 years?
Read the detailed description
This study is a randomised controlled crossover design with a week wash-out period for investigating the acute (2 hrs), short-term (7 days), and acute on short-term (7 days, 2 hrs) effects of black rice consumption on the cognitiv function, inflammation, and vascular function in older adults aged 50-80 years. The cognitive function will be assessed using computer-based test via Gorilla platform. The inflammatory mediators will be measured in a blood sample. The vascular function will be tested by Laser Doppler imaging with iontophoresis (LDI), blood pressure (BP) and heart rate (HR).
Eligible volunteers will be asked to attend the Hugh Sinclair Unit of Human Nutrition for 1 screening visit and 4 study visits.
The enrolment, volunteers will be recruited by poster, E-mail, or telephone. If they are interested in the study and meet the criteria, volunteers will be provided with the participant information sheet explaining the nature and requirements of study. The volunteers who are interested in attending the study will be asked to fill out the health and lifestyle screening questionnaires online link. The potentially eligible volunteers will be invited to attend a screening visit at the Hugh Sinclair Unit of Human Nutrition.
For screening visit (approximately 1-1.5 h), the researcher will explain all the details of the study to volunteers and confirm information in a screening questionnaire. The volunteers who meet the study criteria will be asked to sign the informed consent before partaking in the study. Height, weight, waist circumference, BP, and HR will be measured. Then, global cognitive performance (MMSE test) will be assessed. Inclusion/exclusion criteria will then be reviewed for participant eligibility. Then, they will be asked to perform the demo cognitive tests (30 min). The volunteers will be provided with the participant information booklet which contains the guidelines on what to do during the study and will be invited to attend the study in following week. the volunteers will be asked to fill out food frequency questionnaire prior to first visit.
For study visit 1-4, the volunteers will be asked to fast 8 hours in advance. They will be asked to consume a low the polyphenol rich diet for 24 hours in advance of 1st and 3rd study visit. As soon as they arrive at the nutritional unit, the 15 ml of venous blood will be taken, followed by cognitive testing and BP, HR and LDI will be completed at baseline (35-40 min). After that, the volunteers will receive cooked black rice or control cooked brown rice in a random order served with omelette and 1 glass of water. The volunteers will be asked to eat tested meal within 20 minutes. Then, 2 hours after consumption, the cognitive function will be then assessed, followed by LDI, BP and HR measurements.
For the short-term intervention (to be continued after 1st and 3rd study visit), the volunteers will be provided raw rice and a rice cooker for cooking at home for a further 7 days. The volunteers will be asked to have daily rice consumption (1 meal per day) with avoiding anthocyanin rich food but maintain habitual physical activity during study. In addition, they will be asked to do daily check list to confirm study compliance during trial.
A power calculation based on three similar studies investigating the acute effect of anthocyanin-rich food consumption on cognitive function in middle aged-older adults which suggested that 24 participants (include 10% attribution rate) should provide the sufficient statistic power (Average Effect size=0.64, α=0.05, Power=0.8).
the collected data will be anonymised by providing each participant with unique identification number. The key file will be stored securely in a password protection folder stored in the University-managed cloud. Following completion of the study, the data will be fully anonymised before being archived. Only the applicants named on this form will be digital access to the data and only the researchers directly related to the study will have physical access to keys to the filing cabinets where the paper forms will be stored.
- Conditions
- Older Adults
- Being tested
- Black rice (Intervention), Brown rice (Control)
- Keywords
- Cognitive function, Inflammation, Memory, Older adults
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black rice (Intervention)Other
210 g of cooked black rice
Brown rice (Control)Other
210 g of cooked brown rice
| Study group | Role | What they receive |
|---|---|---|
| Black rice | Experimental | Black rice (210g/meal). Acute study: the volunteers will be asked to eat black rice meal and measured outcomes at 2 hours after consumption.
Short-term study: the volunteers will be asked to consume black rice meals for 7 consecutive days. Receives: Other: Black rice (Intervention); Other: Brown rice (Control) |
| Brown rice | Placebo comparator | Brown rice (210g/meal). Acute study: the volunteers will be asked to eat brown rice meal and measured outcomes at 2 hours after consumption.
Short-term study: the volunteers will be asked to consume brown rice meals for 7 consecutive days. Receives: Other: Black rice (Intervention); Other: Brown rice (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning (RAVLT)
This task consists of 5 consecutive free recalls of the same 15 nouns presented as a first auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. After 15 words had been presented, participants will be asked to say aloud each word as many as they can recall in any order (approximately a minute). The session will be occurred five times. Then, the participants listen an auditory list of 15 words (list B) and will be asked to say aloud each word as many as they can recall in any order. The number of correct words will be counted and averaged of five trials (list A).
Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Digit span Forward and Backward tasks
In this task, the series of digits (numbers) of varying length (spans of 2-9 for forward and 2-8 for backward). It consists of 8 items of forward and 7 items of backward tasks and has 2 trials for each item. The forward and backward digit span tasks, the number will be presented on computer screen an increasingly longer series of digits at a rate of 1 digit/s. The participants will be asked to repeat the number by pressing number on the keyboard. The score will be the maximum of digits of correct both trials, prior to failing two consecutive trials at any one span size.
Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Stroop task
The participants were presented with the words 'GREEN', 'BLUE', 'RED' and 'YELLOW', which were displayed either in the same colour ink as the meaning of the word (congruent trials) or in a colour inconsistent with the meaning of the word (incongruent trials). The participant will be instructed to respond to the colour in which the word is presented rather than the meaning of the word, by pressing a corresponding key on the keyboard. There were 96 trials in total and the task lasted for approximately four minutes. The primary dependent variable was reaction time for correct responses.
Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
The Digit Symbol-Substitution Task (DSST)
Participants are given a table pairing the digits 1 through 9 with nine distinct symbols. Below the table, there is four rows of 25 boxes, each containing a number from one to nine with a blank box underneath. The numbered boxes will be in a random order. Starting at the beginning of the first row and working from left to right down the page, participants will be asked to fill the correct symbol in the blank box using the key at the top of the page. Participants were given 90 seconds to fill in as many boxes as possible in sequential order and the total number of correctly completed boxes will be used to indicate processing speed.
Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Secondary outcomes (8)
High sensitive C reactive protein (hs-CRP)
Serum hs-CRP (mg/L) will be analyzed by automated Enzyme immunoassays (ELISA).
Measured: Day 0, Day 7
Serum inflammatory markers
All serum inflammatory markers including, IL-6 (pg/ml), IL-1β (pg/ml), and TNF-α (pg/ml) will be analyzed by automated Enzyme immunoassays (ELISA).
Measured: Day 0, Day 7
Laser Doppler imaging (LDI)
The microvascular blood flow will be measured by LDI technique which assesses the changing of skin blood flow in response to acetylcholine and sodium nitroprusside by iontophoresis.
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Blood pressure (BP)
BP (mmHg) will be measeured by Omron BP monitor.
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Heart rate (HR)
HP (beat per minute, BPM) will be measeured by Omron BP monitor.
Measured: Day 0, 2hrs, Day 7, Day 7-2hrs
Vascular cell adhesion protein 1 (VCAM-1)
Serum VCAM-1(ng/ml) will be analyzed by automated ELISA.
Measured: Day 0, Day 7
Intercellular adhesion molecule-1 (ICAM-1)
Serum ICAM-1 (ng/ml) will be analyzed by automated ELISA.
Measured: Day 0, Day 7
Brain-derived neurotrophic factor (BDNF)
Serum BDNF (pg/ml) will be analyzed by automated ELISA.
Measured: Day 0, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start5 Dec 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, open-label, crossover design with a week wash-out period for investigating the acute and short-term effects of black rice consumption on the cognitive function, inflammation and microvascular function in older adults.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy Spencer, PhD, Principal investigator, Department of Food and Nutritional Sciences, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583785
- Sponsor's protocol ID
- UREC 23/30
- Acronym
- RICE
- Status last verified
- Aug 2024
- First submitted
- 15 May 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mekhora C, Lamport DJ, Spencer JPE. Impact of anthocyanin-rich black rice consumption on cognitive function, inflammation and microvascular function in older adults: a crossover intervention trial. Food Funct. 2026 Feb 9;17(3):1311-1325. doi: 10.1039/d5fo04351d.
PubMed 41528201
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anthocyanin-Rich Black Rice Consumption on Cognitive Function, Inflammation and Micro-vascular Function in Older Adults
- ClinicalTrials.gov ID
- NCT06583785
- Acronym / sponsor ID
- RICE / UREC 23/30
- Conditions
- Older Adults
- Keywords
- Cognitive function, Inflammation, Memory, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Sep 2024 (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.
Cognitive (brain) function, especially memory, gradually declines during ageing, which may in part be caused by an increase in systemic inflammation as well as a reduction in vascular functions and cerebral blood flow. Blood inflammatory mediators such as c-reactive protein (CRP) and interleukin-6 (IL-6) found to be significantly higher among people over 65 years compared to younger age groups.
Anthocyanins is water-soluble compounds giving blue, purple and red colours in fruits and vegetables. Anthocyanins have been demonstrated to improve cognitive function, inhibit inflammation, and protect cardiovascular health. Black rice contains high amounts of anthocyanins mainly cyanidin 3-glucoside and peonidin 3-glucoside as well as various nutritional compounds such as carbohydrate, vitamin B, vitamin E and fibre. Previous studies reported health benefits of black rice, including anti-inflammation, antioxidative stress, anti-diabetes, and improved cognitive function. However, the effect of black rice consumption on cognitive function related to inflammation has not been studied in humans.
Therefore, this study aims evaluate the acute \& short-term effects of black rice consumption on the cognitive function, inflammation, and vascular function in older adults aged 50-80 years.
The primary and secondary research questions of this study will address:
- Do the acute and short-term anthocyanin-rich black rice intakes improve cognitive function in older adults aged 50-80 years?
- Do the acute and short-term anthocyanin-rich black rice intakes modulate inflammatory status and microvascular function in older adults aged 50-80 years?
Detailed description
This study is a randomised controlled crossover design with a week wash-out period for investigating the acute (2 hrs), short-term (7 days), and acute on short-term (7 days, 2 hrs) effects of black rice consumption on the cognitiv function, inflammation, and vascular function in older adults aged 50-80 years. The cognitive function will be assessed using computer-based test via Gorilla platform. The inflammatory mediators will be measured in a blood sample. The vascular function will be tested by Laser Doppler imaging with iontophoresis (LDI), blood pressure (BP) and heart rate (HR).
Eligible volunteers will be asked to attend the Hugh Sinclair Unit of Human Nutrition for 1 screening visit and 4 study visits.
The enrolment, volunteers will be recruited by poster, E-mail, or telephone. If they are interested in the study and meet the criteria, volunteers will be provided with the participant information sheet explaining the nature and requirements of study. The volunteers who are interested in attending the study will be asked to fill out the health and lifestyle screening questionnaires online link. The potentially eligible volunteers will be invited to attend a screening visit at the Hugh Sinclair Unit of Human Nutrition.
For screening visit (approximately 1-1.5 h), the researcher will explain all the details of the study to volunteers and confirm information in a screening questionnaire. The volunteers who meet the study criteria will be asked to sign the informed consent before partaking in the study. Height, weight, waist circumference, BP, and HR will be measured. Then, global cognitive performance (MMSE test) will be assessed. Inclusion/exclusion criteria will then be reviewed for participant eligibility. Then, they will be asked to perform the demo cognitive tests (30 min). The volunteers will be provided with the participant information booklet which contains the guidelines on what to do during the study and will be invited to attend the study in following week. the volunteers will be asked to fill out food frequency questionnaire prior to first visit.
For study visit 1-4, the volunteers will be asked to fast 8 hours in advance. They will be asked to consume a low the polyphenol rich diet for 24 hours in advance of 1st and 3rd study visit. As soon as they arrive at the nutritional unit, the 15 ml of venous blood will be taken, followed by cognitive testing and BP, HR and LDI will be completed at baseline (35-40 min). After that, the volunteers will receive cooked black rice or control cooked brown rice in a random order served with omelette and 1 glass of water. The volunteers will be asked to eat tested meal within 20 minutes. Then, 2 hours after consumption, the cognitive function will be then assessed, followed by LDI, BP and HR measurements.
For the short-term intervention (to be continued after 1st and 3rd study visit), the volunteers will be provided raw rice and a rice cooker for cooking at home for a further 7 days. The volunteers will be asked to have daily rice consumption (1 meal per day) with avoiding anthocyanin rich food but maintain habitual physical activity during study. In addition, they will be asked to do daily check list to confirm study compliance during trial.
A power calculation based on three similar studies investigating the acute effect of anthocyanin-rich food consumption on cognitive function in middle aged-older adults which suggested that 24 participants (include 10% attribution rate) should provide the sufficient statistic power (Average Effect size=0.64, α=0.05, Power=0.8).
the collected data will be anonymised by providing each participant with unique identification number. The key file will be stored securely in a password protection folder stored in the University-managed cloud. Following completion of the study, the data will be fully anonymised before being archived. Only the applicants named on this form will be digital access to the data and only the researchers directly related to the study will have physical access to keys to the filing cabinets where the paper forms will be stored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, crossover design with a week wash-out period for investigating the acute and short-term effects of black rice consumption on the cognitive function, inflammation and microvascular function in older adults.
| Arm | Type | Receives |
|---|---|---|
| Black rice | Experimental | Other: Black rice (Intervention), Other: Brown rice (Control)Black rice (210g/meal). Acute study: the volunteers will be asked to eat black rice meal and measured outcomes at 2 hours after consumption. Short-term study: the volunteers will be asked to consume black rice meals for 7 consecutive days. |
| Brown rice | Placebo comparator | Other: Black rice (Intervention), Other: Brown rice (Control)Brown rice (210g/meal). Acute study: the volunteers will be asked to eat brown rice meal and measured outcomes at 2 hours after consumption. Short-term study: the volunteers will be asked to consume brown rice meals for 7 consecutive days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50-80 years
- General healthy status
- Body Mass Index (BMI)18.5-35 kg/m2
Key exclusion criteria (17 listed)
- Taking anti-inflammatory drugs (e.g., aspirin, warfarin, ibuprofen)
- Having sign of infections or acute inflammation (e.g., fever, chills, sore throat, nasal congestion, moderate-severe pain, swelling-redness)
- Received antibiotics within the past 3 months
- Taking dietary supplements (e.g., vitamins, minerals) at high doses (e.g., more than 200% of the UK's reference nutrient intakes)
- Taking hormone replacement therapy, if you are menopausal
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 |
|---|---|---|
| Black rice (Intervention)210 g of cooked black rice | Other | Black rice, Brown rice |
| Brown rice (Control)210 g of cooked brown rice | Other | Black rice, Brown rice |
Primary outcome
Rey Auditory Verbal Learning (RAVLT)
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
This task consists of 5 consecutive free recalls of the same 15 nouns presented as a first auditory list (list A), followed by recall of a further 15 nouns presented as an interference list (list B) which is recalled only once. After 15 words had been presented, participants will be asked to say aloud each word as many as they can recall in any order (approximately a minute). The session will be occurred five times. Then, the participants listen an auditory list of 15 words (list B) and will be asked to say aloud each word as many as they can recall in any order. The number of correct words will be counted and averaged of five trials (list A). Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Digit span Forward and Backward tasks
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
In this task, the series of digits (numbers) of varying length (spans of 2-9 for forward and 2-8 for backward). It consists of 8 items of forward and 7 items of backward tasks and has 2 trials for each item. The forward and backward digit span tasks, the number will be presented on computer screen an increasingly longer series of digits at a rate of 1 digit/s. The participants will be asked to repeat the number by pressing number on the keyboard. The score will be the maximum of digits of correct both trials, prior to failing two consecutive trials at any one span size. Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
Stroop task
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
The participants were presented with the words 'GREEN', 'BLUE', 'RED' and 'YELLOW', which were displayed either in the same colour ink as the meaning of the word (congruent trials) or in a colour inconsistent with the meaning of the word (incongruent trials). The participant will be instructed to respond to the colour in which the word is presented rather than the meaning of the word, by pressing a corresponding key on the keyboard. There were 96 trials in total and the task lasted for approximately four minutes. The primary dependent variable was reaction time for correct responses. Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
The Digit Symbol-Substitution Task (DSST)
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
Participants are given a table pairing the digits 1 through 9 with nine distinct symbols. Below the table, there is four rows of 25 boxes, each containing a number from one to nine with a blank box underneath. The numbered boxes will be in a random order. Starting at the beginning of the first row and working from left to right down the page, participants will be asked to fill the correct symbol in the blank box using the key at the top of the page. Participants were given 90 seconds to fill in as many boxes as possible in sequential order and the total number of correctly completed boxes will be used to indicate processing speed. Measurements: at baseline (Day 0), acute intervention (2hrs), 7 days short-term intervention (Day 7) and acute on short-term intervention (Day7-2hrs)
8 secondary outcomes
High sensitive C reactive protein (hs-CRP)
Time frame: Day 0, Day 7
Serum inflammatory markers
Time frame: Day 0, Day 7
Laser Doppler imaging (LDI)
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
Blood pressure (BP)
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
Heart rate (HR)
Time frame: Day 0, 2hrs, Day 7, Day 7-2hrs
Vascular cell adhesion protein 1 (VCAM-1)
Time frame: Day 0, Day 7
Intercellular adhesion molecule-1 (ICAM-1)
Time frame: Day 0, Day 7
Brain-derived neurotrophic factor (BDNF)
Time frame: Day 0, Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 41528201Mekhora C, Lamport DJ, Spencer JPE. Impact of anthocyanin-rich black rice consumption on cognitive function, inflammation and microvascular function in older adults: a crossover intervention trial. Food Funct. 2026 Feb 9;17(3):1311-1325. doi: 10.1039/d5fo04351d.
- 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.
Jeremy Spencer, PhD principal investigator
Department of Food and Nutritional Sciences, University of Reading
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black rice (Intervention) in people with Older Adults, run by University of Reading at 2 sites in United Kingdom.
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 17 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Spencer, PhD (+44 1183788724, j.p.e.spencer@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Learning (RAVLT) (time frame: Day 0, 2hrs, Day 7, Day 7-2hrs). The study lists 4 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 NCT06583785, which also lists 1 linked publication.
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 4 Sep 2024.