Health Status Clinical Trial
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.
NCT number | NCT04009564 |
Other study ID # | DSCPM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 20, 2019 |
Est. completion date | March 30, 2020 |
Verified date | July 2019 |
Source | Newcastle University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 7, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NU-Food Research Facility | Newcastle upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Change form Baseline for each visit only | |
Secondary | 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). | Change from baseline 45 minutes post dose and at 90 minutes post dose. | |
Secondary | 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. | Change from baseline 45 minutes post dose and at 90 minutes post dose. |
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