Black Rice Consumption on Cognitive Function, Inflammation and Microvascular Function in Older Adults

NCT06583785 | Recruiting

• 1 other identifier: UREC 23/30
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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. 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:

1. 1.Do the acute and short-term anthocyanin-rich black rice intakes improve cognitive function in older adults aged 50-80 years?
2. 2.Do the acute and short-term anthocyanin-rich black rice intakes modulate inflammatory status and microvascular function in older adults aged 50-80 years?

Conditions

Older Adults

Keywords

Cognitive function; Inflammation; Memory; Older adults

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  Day 0, 2hrs, Day 7, Day 7-2hrs

Secondary Outcomes (8)

• High sensitive C reactive protein (hs-CRP)

  Day 0, Day 7

• Serum inflammatory markers

  Day 0, Day 7

• Laser Doppler imaging (LDI)

  Day 0, 2hrs, Day 7, Day 7-2hrs

• Blood pressure (BP)

  Day 0, 2hrs, Day 7, Day 7-2hrs

• Heart rate (HR)

  Day 0, 2hrs, Day 7, Day 7-2hrs

Study Arms (2)

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.

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.

Other: Black rice (Intervention); Other: Brown rice (Control)

Interventions

Black rice (Intervention) OTHER

210 g of cooked black rice

Black rice; Brown rice

Brown rice (Control) OTHER

210 g of cooked brown rice

Black rice; Brown rice

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-80 years
• General healthy status
• Body Mass Index (BMI)18.5-35 kg/m2

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (2)

Hugh Sinclair Unit of Human Nutrition

Reading, UK, RG2 6AP, United Kingdom

RECRUITING

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, RG2 6AP, United Kingdom

RECRUITING

Related Publications (1)

• 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 Jan 13. doi: 10.1039/d5fo04351d. Online ahead of print.

  PMID: 41528201 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jeremy Spencer, PhD

  Department of Food and Nutritional Sciences, University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Spencer, PhD

CONTACT

+44 1183788724; j.p.e.spencer@reading.ac.uk

Chusana Mekhora, MSc

CONTACT

+44 7824 42 2127; c.mekhora@pgr.reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: September 4, 2024
• Study Start: December 5, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)