Blueberry Study Aimed at Improving Cognition and Peripheral Blood Flow

NCT04015258 | Completed

• 1 other identifier: Research Ethics 10113
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Blueberries are rich in the content of a variety of biologically active chemicals that contribute to their health properties. The consumption of blueberries has beneficial effects on vascular function and brain health and function. Blueberries are present in human diet in a number of forms, but the investigator do not know which form is best for health and why people respond differently to eating blueberries. The aim of the present study is to assess the effects of 1 week's supplementation of whole blueberries or freeze-dried blueberry powder or encapsulated blueberry components on vascular function and brain health and function. Investigators will then categorise participants as those who have large effects of the intervention (responders) and those that don't show much effect at all (non-responders). Then the investigators will look into the role that genes play in this response and determine if metabolism is similar in these groups of participants. Any changes in participants' brain health and vascular function will be linked to these metabolic and genomic pathways, and this will help the investigators to further understand how blueberry consumption can benefit human health.

Conditions

Vascular Stiffness; Cognitive Change; Blood Pressure

Keywords

blueberry; intervention; endothelial function; cognition; metabolomics; genomics

Outcome Measures

Primary Outcomes (9)

• Accuracy of participant recalling word list Immediately

  will be assessed via COMPASS (Computerised Mental Performance Assessment System) tasks by participants recalling word list immediately after displays; the result will be presented as accuracy (%) and as an assessment of short-term memory

  1 minute

• Correct responses of participants counting down from certain number by subtracting 3

  will be assessed via COMPASS tasks by participants counting down from certain number by threes. The result will be presented as correct responses and as an assessment of executive function

  5 minutes

• Correct responses of participants counting down from certain number by subtracting 7

  will be assessed via COMPASS tasks by participants counting down from certain number by sevens, the result will be presented as correct responses and as an assessment of executive function

  5 minutes

• Reaction time of participants' vigilance during rapid visual tracking and accurate selection of target digit stimuli

  will be assessed via COMPASS tasks by measuring participants' vigilance during rapid visual tracking and accurate selection of target stimuli, presented by reaction time in millisecond (ms), as an assessment of attention and psychomotor speed

  5 minutes

• Accuracy of participant recalling word list 30 minutes after displays

  will be assessed via COMPASS tasks by participants recalling word list after 30 minutes, the result will be presented as accuracy (%) and as an assessment of memory

  5 minutes

• Brachial-radial distance

  brachial-radial distance in meters (m), will be measured by tape

  1 minute

• Pulse wave time

  time of the pulse wave moves down from brachial to radial artery in seconds (s), will be measured by Sphygmocor (ScanMed medical)

  10 minutes

• Pulse wave velocity (PWV)

  will be measured by Sphygmocor (ScanMed medical), by outcome 7 pulse wave time (s) dividing outcome 6 brachial-radial distance (m), PWV will be presented in the units of m/s, as an assessment of endothelial function

  10 minutes

• Blood Pressure

  will be assessed by BP monitor and reported in the units of mm Hg

  10 minutes

Secondary Outcomes (5)

• Inter-cellular Adhesion Molecules (ICAMs) and Vascular Cell Adhesion Molecules (VCAMs)

  1 day

• C-reactive Protein (CRP)

  1 day

• Plasma Lipid Status

  1 day

• Untargeted Plasma and Urine Metabolites

  1 day

• Single Nucleotide Polymorphisms (SNPs)

  7 days

Study Arms (3)

Blueberries

EXPERIMENTAL

Fresh blueberries purchased from local supermarket will be distributed to each participant for 1 week's consumption, 160 grams per day

Dietary Supplement: Blueberries

Blueberry powder

EXPERIMENTAL

Freeze-dried blueberry powder will be distributed to each participant for 1 week's consumption, 20 grams per day, equivalent to 160 grams of fresh blueberries

Dietary Supplement: Blueberry powder

Blueberry components capsules

PLACEBO COMPARATOR

Encapsulated microcrystalline cellulose powder will be blinded as blueberry components capsules to be distributed to each participant for 1 week's consumption

Dietary Supplement: Blueberry components capsules

Interventions

Blueberries DIETARY_SUPPLEMENT

fresh spanish blueberries

Blueberries

Blueberry powder DIETARY_SUPPLEMENT

freeze-dried blueberry powder

Blueberry powder

Blueberry components capsules DIETARY_SUPPLEMENT

encapsulated blueberry components (microcrystalline cellulose powder in actual)

Blueberry components capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Interested in taking part in the study
• Healthy
• Aged 18-60 years (inclusive)

You may not qualify if:

• Smoking
• Aged under 18 or over 60
• Blood Pressure ≥ 145/100 mmHg and are taking medication
• Have vascular disease, or other cardiac abnormalities
• Have previously suffered any head injuries, history of seizures or other neurological disorders
• Have any metabolic disorders, malabsorption syndromes or gastrointestinal complications
• Current use of above disease relevant prescription medications (excluding contraception)
• Irregular bowel function (less than 1 bowel movement per day)
• Regularly consume blueberries/blueberry-contained products more than twice per week
• Have regularly used nutritional supplements or medications within the previous 3 months (defined as more than 3 consecutive days or 4 days in total)
• Learning difficulties and dyslexia
• Visual impairment that cannot be corrected with glasses or contact lenses including colour blindness
• Currently suffer from migraines (\> 1 per month)
• Body mass index (BMI) under 18.5 or over 30
• Pregnancy, seeking to become pregnant, or current lactation

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

blueberry extract

Study Officials

• Yueyue Wang

  Miss

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: July 10, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)