Health StatusNCT04009564
Effect of Date Seeds Coffee on Mood and Cognitive Performance
A study testing Date coffee and Normal coffee in people with Health Status, run by Newcastle University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Status
- What is being tested?
- Date coffee and Normal coffee
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young volunteers age between 18 to 35
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
About this study
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.
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.
Read the 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.
- Conditions
- Health Status
- Being tested
- Date coffee, Normal coffee, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date coffeeDietary supplement
45 g of date seeds coffee in 280 ml of water
Normal coffeeDietary supplement
6 g of normal coffee in 280ml of water
PlaceboDietary supplement
water, food colouring and coffee flavouring
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: Change form Baseline for each visit only
Caffeine research Visual Analogue Scales
A caffeine research Visual Analogue Scales which comprises of 7 scales (relaxed, alert, jittery, tired, tense, headache and overall mood).
Measured: Change from baseline 45 minutes post dose and at 90 minutes post dose.
Change in Mood using Bond Lader Visual Analogue Scales
This widely used set of 16 100 mm VASs yields three extensively validated factor scores: alertness, calmness and contentment.
Measured: Change from baseline 45 minutes post dose and at 90 minutes post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start20 Jun 2019
- Primary completion7 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009564
- Sponsor's protocol ID
- DSCPM
- Status last verified
- Jul 2019
- First submitted
- 19 Dec 2018
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04009564
- Acronym / sponsor ID
- DSCPM
- Conditions
- Health Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Date seeds filtered coffee | Experimental | Dietary Supplement: Date coffeeEach 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 |
| Normal filtered coffee | Experimental | Dietary Supplement: Normal coffeeEach 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 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young volunteers age between 18 to 35
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date coffee45 g of date seeds coffee in 280 ml of water | Dietary supplement | Date seeds filtered coffee |
| Normal coffee6 g of normal coffee in 280ml of water | Dietary supplement | Normal filtered coffee |
| Placebowater, food colouring and coffee flavouring | Dietary supplement | Placebo |
Primary outcome
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).
3 secondary outcomes
Change in Caffeine consumption using caffeine consumption questionnaire
Time frame: 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.
Change in Mood using Bond Lader Visual Analogue Scales
Time frame: Change from baseline 45 minutes post dose and at 90 minutes post dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Date coffee and Normal coffee in people with Health Status, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Change from baseline at 45 minutes post dose and at 90 minutes post dose for each visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.