NCT04009564

Brief Summary

Limited utilizations of date seeds have previously been explored, and so previously wastage has often been the normality. However, research now indicates that several fruit seeds contain higher concentrations of beneficial total phytochemicals within their seeds in comparison to the flesh. As well as high nutritional values of date seeds for fibre, protein and micronutrients, this increased phytochemical content has been proven to be true for date seeds, with mainly phenolic acids (24.6 g k GAE) 3 and total flavonoids (3.67 g k RE). With the seeds presently being used to produce new coffee products, it raises questions on whether consumption of date seeds can alter mood and cognitive behaviour and therefore research into investigate the acute effect of date seeds coffee on mood and cognitive function on healthy young volunteers. However, to the best of the research team knowledge, this is the first human trial to investigate these effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

First Submitted

Initial submission to the registry

December 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

August 31, 2020

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

December 19, 2018

Last Update Submit

August 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • The average of the change in 9 cognitive indexes including: Attentional Intensity, Sustained Attention, Attentional Fluctuation, Memory Retrieval Speed, Cognitive Reaction Time, Working Memory Capacity, Episodic Memory Capacity, Quality of Memory

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

    Change from baseline at 45 minutes post dose and at 90 minutes post dose for each visit

Secondary Outcomes (3)

  • Change in Caffeine consumption using caffeine consumption questionnaire

    Change form Baseline for each visit only

  • Caffeine research Visual Analogue Scales

    Change from baseline 45 minutes post dose and at 90 minutes post dose.

  • Change in Mood using Bond Lader Visual Analogue Scales

    Change from baseline 45 minutes post dose and at 90 minutes post dose.

Study Arms (3)

Date seeds filtered coffee

EXPERIMENTAL

Each participant will consume this arm in a visit has been allocated by Latin Square randomisation order: 45 g of date seeds coffee in 280 ml of boiled water, coffee flavour and brown food colouring ( made using a filter coffee machine). it will be served in a paper cup with lid

Dietary Supplement: Date coffee

Normal filtered coffee

EXPERIMENTAL

Each participant will consume this arm in a visit has been allocated by Latin Square randomisation order: 6 g of coffee in 280 ml of boiled water (made using a filter coffee machine) it will be served in a paper cup with lid

Dietary Supplement: Normal coffee

Placebo

PLACEBO COMPARATOR

Each participant will consume this arm in a visit has been allocated by Latin Square randomisation order: 280 of boiled water, coffee flavour and brown food colouring it will be served in a paper cup with lid

Dietary Supplement: Placebo

Interventions

Date coffeeDIETARY_SUPPLEMENT

45 g of date seeds coffee in 280 ml of water

Date seeds filtered coffee
Normal coffeeDIETARY_SUPPLEMENT

6 g of normal coffee in 280ml of water

Normal filtered coffee
PlaceboDIETARY_SUPPLEMENT

water, food colouring and coffee flavouring

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy young volunteers age between 18 to 35

You may not qualify if:

  • Participants will be ineligible to participate in the study if any of the following apply:
  • Have a BMI above 35kg/m2
  • Smokers or tobacco product consumers which includes electronic cigarettes
  • Are taking any illicit or prescribed drugs.
  • Have a history of, or currently, abuse alcohol
  • Have a history of dyslexia, ADHD, learning difficulties or colour blindness,
  • Females who are pregnant, lactating or seeking to become pregnant, or are at risk of pregnancy as they to do not use birth control measures
  • Have allergies to any food product.

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

December 19, 2018

First Posted

July 5, 2019

Study Start

June 20, 2019

Primary Completion

March 7, 2020

Study Completion

March 30, 2020

Last Updated

August 31, 2020

Record last verified: 2019-07

Locations