NCT02810769

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

November 8, 2012

Last Update Submit

June 20, 2016

Conditions

Outcome Measures

Primary Outcomes (5)

  • Blood glucose

    Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose

  • Blood lactate

    Change from baseline at 60, 140, 180, 200, 230 and 350 minutes post dose

  • Monoamine oxidase B inhibition

    Change from baseline at 350 minutes post dose

  • Cognitive Measures - Memory- Assessed using a computerised cognitive batter.

    Change from baseline 60, 150, 240 and 360 minutes post dose

  • Cognitive Measures - Attention- Assessed using a computerised cognitive batter.

    Change from baseline 60, 150, 240 and 360 minutes post dose

Study Arms (3)

Control

PLACEBO COMPARATOR

Sugar matched control containing no phytochemicals

Dietary Supplement: Control

Juiced berry drink

EXPERIMENTAL

Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Dietary Supplement: Berry drink

Powdered berry drink

EXPERIMENTAL

Berry drink made up from a powdered concentrate. each drink will be standardised to contain 500mg of polyphenols

Dietary Supplement: Powdered berry drink

Interventions

Berry drinkDIETARY_SUPPLEMENT

Cold pressed berry drink standardised to contain 500mg of berry polyphenols

Juiced berry drink
ControlDIETARY_SUPPLEMENT

Sugar matched control containing berry flavouring and no phytochemicals

Control
Powdered berry drinkDIETARY_SUPPLEMENT

Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols

Powdered berry drink

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Non-smokers
  • Aged between 40 and 60 years

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre

Newcastle upon Tyne, Newcastle Upon-Tyne, NE18ST, United Kingdom

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2012

First Posted

June 23, 2016

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations