Clinical trial NCT04009564: Effect of Date Seeds Coffee on Mood and Cognitive Performance
Official title: Investigating the Acute Effects of Mood and Cognitive Performance Following the Administration of a Coffee Made of Date Seeds on Healthy Young Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Status
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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:

1. Have a BMI above 35kg/m2
2. Smokers or tobacco product consumers which includes electronic cigarettes
3. Are taking any illicit or prescribed drugs.
4. Have a history of, or currently, abuse alcohol
5. Have a history of dyslexia, ADHD, learning difficulties or colour blindness,
6. 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
7. Have allergies to any food product.

Primary outcomes:
measure: 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
timeFrame: Change from baseline at 45 minutes post dose and at 90 minutes post dose for each visit
Secondary outcomes:
measure: Change in Caffeine consumption using caffeine consumption questionnaire
timeFrame: Change form Baseline for each visit only
measure: Caffeine research Visual Analogue Scales
timeFrame: Change from baseline 45 minutes post dose and at 90 minutes post dose.
measure: Change in Mood using Bond Lader Visual Analogue Scales
timeFrame: Change from baseline 45 minutes post dose and at 90 minutes post dose.
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: NU-Food Research Facility
state: Tyne And Wear
Study officials:
References: