- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009564
Effect of Date Seeds Coffee on Mood and Cognitive Performance
Investigating the Acute Effects of Mood and Cognitive Performance Following the Administration of a Coffee Made of Date Seeds on Healthy Young Volunteers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction
Seeds of the date palm (P. dactylifera) are a very rich source of bioactive compounds, thus constituting strong candidates for functional food additives and nutraceuticals. Many promising results were observed when the effect of date flesh and seeds consumption have been studied in animals, for their role as either a protective1 against neurodegenerative 2,4,5 diseases, or as a cure for it 2. Most of the observed effects were attributed to the antioxidant and anti-inflammatory properties in dates flesh and seeds fruit due to it high content of phenolic compounds 3.
Rational For years, date seeds were considered a waste, having no other uses except for feeding animals. However, as has already been demonstrated in other fruits and corresponding seeds, total phytochemical content of the date seeds was higher than in the edible flesh9. Date seeds have also been shown to have an excellent nutritional quality due to high amounts of fibre (676-742 g/kg) 3 depending on variety, considerable amounts of minerals, vitamins, lipids and protein. Additionally, date seeds were shown to be rich in antioxidants containing mainly phenolic acids (24.6 g k Gallic Acid equivalent) 3 and total flavonoids (3.67 g k Rutin Equivalent).
Nowadays, and on sight of the aforementioned findings, date seeds are used to make a new coffee product. This ''coffee alternative'' is commercially available and is becoming more popular.
Although, many studies have demonstrated that date seeds possess high antioxidant activities, due to their high content of flavonoids and phenolic compounds, no human trial has investigated the effect of the consumption of date seeds on humans and especially on mood and cognitive behaviour. Therefore, this study, for the first time, to the best of the research team knowledge will investigate the acute effect of date seeds coffee on mood and cognitive function on healthy young volunteers.
Aim The aim of this study is to investigate the acute effects of a coffee made of date seeds on mood and cognitive performance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tyne And Wear
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Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 7RU
- NU-Food Research Facility
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy young volunteers age between 18 to 35
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Date seeds filtered coffee
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
|
45 g of date seeds coffee in 280 ml of water
|
|
Experimental: Normal filtered coffee
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
|
6 g of normal coffee in 280ml of water
|
|
Placebo Comparator: Placebo
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
|
water, food colouring and coffee flavouring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Change from baseline at 45 minutes post dose and at 90 minutes post dose for each visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caffeine consumption using caffeine consumption questionnaire
Time Frame: Change form Baseline for each visit only
|
A paper based questionnaire developed by Erika Bühler et al., 2014.
At the screening visit and on each study day participants will be asked to complete the table in order to build a picture of their individual caffeine habits
|
Change form Baseline for each visit only
|
|
Caffeine research Visual Analogue Scales
Time Frame: Change from baseline 45 minutes post dose and at 90 minutes post dose.
|
A caffeine research Visual Analogue Scales which comprises of 7 scales (relaxed, alert, jittery, tired, tense, headache and overall mood).
|
Change from baseline 45 minutes post dose and at 90 minutes post dose.
|
|
Change in Mood using Bond Lader Visual Analogue Scales
Time Frame: Change from baseline 45 minutes post dose and at 90 minutes post dose.
|
This widely used set of 16 100 mm VASs yields three extensively validated factor scores: alertness, calmness and contentment.
|
Change from baseline 45 minutes post dose and at 90 minutes post dose.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DSCPM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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