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

NCT ID: NCT06583785

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2024-12-31

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

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?

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Black rice

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.

Group Type: EXPERIMENTAL

Black rice (Intervention)

Intervention Type: OTHER

210 g of cooked black rice

Brown rice (Control)

Intervention Type: OTHER

210 g of cooked brown rice

Brown rice

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.

Group Type: PLACEBO_COMPARATOR

Black rice (Intervention)

Intervention Type: OTHER

210 g of cooked black rice

Brown rice (Control)

Intervention Type: OTHER

210 g of cooked brown rice

Interventions

Black rice (Intervention)

210 g of cooked black rice

Intervention Type: OTHER

Brown rice (Control)

210 g of cooked brown rice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Heavy alcohol drinking (> 14 units/week) or a history of alcohol/substance abuse
• Allergies, hypersensitivity, or food intolerances (rice, eggs, soy sauce, vegetable oil)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Paul Edward Spencer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeremy Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Food and Nutritional Sciences, University of Reading

Locations

Hugh Sinclair Unit of Human Nutrition

Reading, UK, United Kingdom

Site Status: RECRUITING

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

Reading, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Jeremy Spencer, PhD

Role: CONTACT

j.p.e.spencer@reading.ac.uk

+44 1183788724

Chusana Mekhora, MSc

Role: CONTACT

c.mekhora@pgr.reading.ac.uk

+44 7824 42 2127

Facility Contacts

Chusana Mekhora

Role: primary

c.mekhora@pgr.reading.ac.uk

07824422127

Jeremy Spencer, PhD

Role: primary

j.p.e.spencer@reading.ac.uk

Other Identifiers

UREC 23/30

Identifier Type: -

Identifier Source: org_study_id