Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
Healthy Volunteers
ID06583785

Impact of Anthocyanin-Rich Black Rice Consumption on Cognitive Function, Inflammation and Microvascular Function in Older Adults

Led by University of Reading · Updated on 2024-09-04

24

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of black rice consumption on cognitive function, inflammation, and vascular health in older adults aged 50 to 80 years. The study focuses on understanding whether anthocyanin-rich black rice can improve memory and cognitive abilities, reduce inflammation, and support vascular function, as these factors tend to decline with age and may be linked to increased inflammatory markers found in older populations. This is a randomized controlled crossover study where participants consume either black rice or brown rice meals. The study measures acute effects 2 hours after eating the rice and short-term effects after 7 days of daily consumption. Participants attend four study visits, during which blood samples are taken to assess inflammatory markers, and cognitive tests are conducted using computer-based platforms. Vascular function is evaluated through laser Doppler imaging, blood pressure, and heart rate measurements. Participants will undergo a screening visit including health assessments and initial cognitive tests. During study visits, participants fast for 8 hours before consuming test meals and then complete cognitive and vascular assessments at baseline and after 2 hours. For the short-term phase, participants consume rice daily at home for 7 days and keep a compliance checklist. The primary outcomes include various cognitive tests, while secondary outcomes track inflammation and vascular markers. Data privacy and safety are maintained throughout, with a total study duration of about two weeks per participant.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 50-80 years
  • General healthy status
  • Body Mass Index (BMI) between 18.5 and 35 kg/m2
Not Eligible

You will not qualify if you...

  • Taking anti-inflammatory drugs such as aspirin, warfarin, or ibuprofen
  • Signs of infection or acute inflammation like fever, chills, sore throat, or swelling
  • Received antibiotics within the past 3 months
  • Taking high-dose dietary supplements exceeding 200% of UK nutrient intakes
  • Using hormone replacement therapy if menopausal
  • Major surgery on head, heart, chest, or abdomen in past 6 months
  • Planning to start a restricted diet or weight loss
  • Diagnosed with neurodegenerative diseases (e.g., dementia, Alzheimer's, Parkinson's, recent stroke)
  • Diagnosed with psychotic disorders (e.g., schizophrenia, bipolar depression, eating disorder)
  • Diagnosed with cardiovascular disease, diabetes, hyperlipidemia, hypertension (above 140/90 mmHg), active cancer, liver or kidney disease
  • Taking medications to lower blood fats, stabilize blood glucose, or lower blood pressure
  • Unable to complete cognitive tests due to visual or hearing impairment
  • Having a pacemaker
  • Having bleeding disorders or blood-related diseases
  • Heavy smoker
  • Heavy alcohol use (more than 14 units/week) or history of substance abuse
  • Allergies or intolerances to rice, eggs, soy sauce, or vegetable oil

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 weeks including wash-out

Participants will consume meals containing either black rice or brown rice during separate study visits and at home as part of a short-term dietary intervention. They will attend four study visits involving fasting, blood sampling, cognitive testing, and vascular measurements before and 2 hours after rice consumption. Participants will consume rice daily at home for 7 days following select visits.

4 in-person study visits

Trial Site Locations

Total: 2 locations

1

Hugh Sinclair Unit of Human Nutrition

Reading, UK, United Kingdom, RG2 6AP

Actively Recruiting

2

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

Reading, United Kingdom, RG2 6AP

Actively Recruiting

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Research Team

J

Jeremy Spencer, PhD

C

Chusana Mekhora, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Impact of anthocyanin-rich black rice consumption on cognitive function, inflammation and microvascular function in older adults: a crossover intervention trial.

Chusana Mekhora, Daniel J Lamport, Jeremy P E Spencer

https://pubmed.ncbi.nlm.nih.gov/41528201