Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02810769
Other study ID # 28AI5
Secondary ID
Status Completed
Phase N/A
First received November 8, 2012
Last updated June 20, 2016
Start date November 2012
Est. completion date May 2013

Study information

Verified date June 2016
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The first study of my PhD showed that acute supplementation of berry extracts can modulate cognitive behaviour in healthy adults. There is a growing body of evidence supporting an improvement in memory and learning performance in animal models following the ingestion of flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However, study 2, showed no effect on any aspects of memory in healthy young adults after supplementation of the berry extracts. It is hypothesised that the lack of behavioural effects on memory of the berry juice in study 2 was because of the cohort used. These healthy adult participants were already performing near to their peak (Salthouse et al., 2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive benefits.

The aims of the study are to examine if acute supplementation of two berry extracts in an older population can augment memory, attention and executive function. Secondly, the time course of these behavioural effects will be measured by multiple cognitive assessments throughout the day after consumption of the extracts.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria:

- Healthy

- Non-smokers

- Aged between 40 and 60 years

Exclusion Criteria:

- History of neurological, vascular or psychiatric illness.

- BMI greater than 35 kg/m2

- Current diagnosis of depression and/or anxiety.

- History or current diagnosis of drug/alcohol abuse.

- Anaemia.

- Any heart disorder.

- Hypertension

- Any respiratory disorder.

- Diabetes.

- Food intolerances/sensitivities.

- Phenylketonuria.

- Use tobacco products or have ceased in the last 6 months.

- Currently taking, or have taken in the last 2 weeks, any prescribed, illicit or herbal drugs and food supplements.

- Any known active infections.

- HIV antibody positive.

- Currently have, have ever had, or may be at risk of hepatitis.

- Have suffered from jaundice within the last year.

- Have haemophilia or any similar clotting disorder.

- History of head trauma

- History of migraines

- History of learning difficulties

- Any Issues with giving blood samples.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Berry drink
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
Control
Sugar matched control containing berry flavouring and no phytochemicals
Powdered berry drink
Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols

Locations

Country Name City State
United Kingdom Brain, Performance and Nutrition Research Centre Newcastle Upon-Tyne

Sponsors (2)

Lead Sponsor Collaborator
Northumbria University The New Zealand Institute for Plant and Food Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose No
Primary Blood lactate Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose No
Primary Monoamine oxidase B inhibition Change from baseline at 350 minutes post dose No
Primary Cognitive Measures - Memory- Assessed using a computerised cognitive batter. Change from baseline 60, 150, 240 and 360 minutes post dose No
Primary Cognitive Measures - Attention- Assessed using a computerised cognitive batter. Change from baseline 60, 150, 240 and 360 minutes post dose No
See also
  Status Clinical Trial Phase
Completed NCT05534464 - Protein Digestibility in Older and Younger Adults N/A
Completed NCT02796508 - Attention and Memory Training With Video Games in Old Age N/A
Completed NCT02843009 - Fish Oil and Adaptations to Resistance Exercise in Older People N/A
Active, not recruiting NCT04199195 - Microbiome of the Ageing Gut and Its Effect on Human Gut Health and Cognition.
Completed NCT02745275 - Supporting Healthy Aging by Peer Education and Support N/A
Recruiting NCT05822154 - Comprehensive Geriatric Assessment in the Elderly Subjects (PROMISING)
Completed NCT02575742 - Colonic Motility in Constipation and Ageing
Completed NCT02604641 - Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin N/A
Active, not recruiting NCT01466582 - Comorbidity and Aging With HIV
Enrolling by invitation NCT02617719 - Comprehensive Geriatric Assessment in Primary Care: The Fit for Late Life Project N/A
Completed NCT01997320 - Effect of Strength Training and Protein Supplementation on Muscles in the Very-old N/A
Completed NCT01682330 - The Long-term Effects of Training on Muscle Strength and Functionality N/A
Completed NCT02130154 - Brown Adipose Tissue Activity and Age N/A
Completed NCT01451476 - Human Skin Aging: Clinical Parameters and Gene Expression Profiling
Completed NCT00176319 - Leipzig Exercise Intervention in Chronic Heart Failure and Aging Phase 2
Completed NCT02300272 - Health Behaviors and Time-of-Day: Older Adult Cognitive Function
Completed NCT02373111 - Effects of Isoflavone Combined With Astaxanthin on Skin Aging N/A
Completed NCT02603029 - Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin N/A
Completed NCT02393742 - Nitrite Supplementation for Improving Physiological Function in Older Adults N/A
Completed NCT01294137 - Sleep Apnea in Frail Elderly N/A

External Links