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Effect of Date Seeds Coffee on Mood and Cognitive Performance
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Health Status | Dietary Supplement: Date coffee Dietary Supplement: Normal coffee Dietary Supplement: Placebo | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 52 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Basic Science |
| 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. |
| Actual Study Start Date : | June 20, 2019 |
| Actual Primary Completion Date : | March 7, 2020 |
| Actual Study Completion Date : | March 30, 2020 |
| 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
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Dietary Supplement: Date coffee
45 g of date seeds coffee in 280 ml of water
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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
|
Dietary Supplement: Normal coffee
6 g of normal coffee in 280ml of water
|
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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
|
Dietary Supplement: Placebo
water, food colouring and coffee flavouring
|
- 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 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
- 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 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.
| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
| United Kingdom | |
| NU-Food Research Facility | |
| Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 7RU | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | December 19, 2018 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | August 31, 2020 | ||||
| Actual Study Start Date ICMJE | June 20, 2019 | ||||
| Actual Primary Completion Date | March 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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).
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Date Seeds Coffee on Mood and Cognitive Performance | ||||
| Official Title ICMJE | Investigating the Acute Effects of Mood and Cognitive Performance Following the Administration of a Coffee Made of Date Seeds on Healthy Young Volunteers. | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Health Status | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
52 | ||||
| Original Estimated Enrollment ICMJE |
44 | ||||
| Actual Study Completion Date ICMJE | March 30, 2020 | ||||
| Actual Primary Completion Date | March 7, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 35 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04009564 | ||||
| Other Study ID Numbers ICMJE | DSCPM | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Newcastle University | ||||
| Study Sponsor ICMJE | Newcastle University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Newcastle University | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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