NCT03350100

Brief Summary

A number of studies have considered the neuroprotective effects of date fruit on neurodegenerative diseases in animals. However, so far no study has addressed the acute effects of date fruit on mood and cognitive performance in humans. This study will investigate the acute effects of two different cultivars of Saudi dates on mood and cognitive performance into healthy volunteers. This study will follow a double blind, randomised, placebo controlled, repeated measures, cross over design with two active treatment arms versus placebo. Treatment orders will be counterbalanced with the use of a Latin Square design. Thirty six healthy participants aged between 18 and 35 will be recruited. Participants will be required to undergo a screening/training visit, followed by three measurement visits at weekly intervals. The trial will last for 3 months in total.

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 Oct 2017

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

October 31, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

November 17, 2017

Last Update Submit

September 21, 2018

Conditions

Mood and Cognitive Performance

Outcome Measures

Primary Outcomes (12)

  • cognition: Simple Reaction Time

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition: Digit Vigilance

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition: Choice Reaction Time

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition: Numeric Working Memory

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition: Spatial Working Memory

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition: Immediate Word Recall

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition:Delayed Word Recall

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition:Word Recognition

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Cognition:Pattern Separation

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • Mood scales Bond Lader

    The Bond and Lader Visual Analogue Scales (1974)

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  • The Profile of Mood States (POMS)

    The Profile of Mood States (POMS; McNair et al., 1992)

    Change from visit 1 to visit 2 to visit 3

  • Blood Glucose level test

    Finger prick

    Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Study Arms (3)

Birhi date cultivar

EXPERIMENTAL

A 48.46 g of freeze dried powder of Birhi date Cultivar which is equivalent to a 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 162.8 mg/100 g of GAE. and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance

Khassab date cultivar

EXPERIMENTAL

A 34.5 g of freeze dried powder of Khassab date Cultivar which is equivalent to A 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 91.52 mg/100 g of GAE. and 0.80 g of fibres,will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance

placebo

PLACEBO COMPARATOR

A 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.

Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance

Interventions

Acute effect of two Saudi cultivars of date fruit on mood and cognitive performanceDIETARY_SUPPLEMENT

Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance at baseline, 45 post-dose, 90 min post-dose and 135 min post-dose

Birhi date cultivarKhassab date cultivarplacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A total of 36 healthy participants aged between 18 and 35 will be recruited through advertisement via poster and flyer. All participants will be required to undergo a screening visit.

You may not qualify if:

  • Healthy participants aged 18-35 with a BMI \>18 \<36 will be recruited from the Newcastle Upon-Tyne area
  • Participants will be considered ineligible to participate in the study if they meet any of the following criteria:
  • They have a BMI above 35kg/m2 or lower than 18kg/m2
  • They smoke or consume tobacco products
  • They are taking any illicit or prescribed drugs
  • They are using dietary supplements, over the counter medicine or recreational drugs
  • They have a history of or currently abuse alcohol
  • They have a history of dyslexia, ADHD, learning difficulties or color blindness
  • They are females who are pregnant, seeking to become pregnant or do not use
  • They have allergies to any food products.
  • They have any metabolic diseases such as type 1 or type 2 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NU-Food Research Facility

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 22, 2017

Study Start

October 31, 2017

Primary Completion

March 29, 2018

Study Completion

April 1, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

GB(1)