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Mood and Cognitive PerformanceNCT03350100

The Effect of Date Fruit on Mood and Cognition in Healthy Adults

A study testing Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance in people with Mood and Cognitive Performance, run by Newcastle University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A number of studies have considered the neuroprotective effects of date fruit on neurodegenerative diseases in animals. However, so far no study has addressed the acute effects of date fruit on mood and cognitive performance in humans. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Mood and Cognitive Performance
What is being tested?
Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
31 Oct 2017to 1 Apr 2018
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

  • A total of 36 healthy participants aged between 18 and 35 will be recruited through advertisement via poster and flyer. All participants will be required to undergo a screening visit.

Who cannot join

  • Healthy participants aged 18-35 with a BMI >18 <36 will be recruited from the Newcastle Upon-Tyne area
  • Participants will be considered ineligible to participate in the study if they meet any of the following criteria:
  • They have a BMI above 35kg/m2 or lower than 18kg/m2
  • They smoke or consume tobacco products
  • They are taking any illicit or prescribed drugs
  • They are using dietary supplements, over the counter medicine or recreational drugs
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  • They have a history of or currently abuse alcohol
  • They have a history of dyslexia, ADHD, learning difficulties or color blindness
  • They are females who are pregnant, seeking to become pregnant or do not use
  • They have allergies to any food products.
  • They have any metabolic diseases such as type 1 or type 2 diabetes.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • NU-Food Research Facility

    Newcastle upon Tyne, Tyne and Wear, NE1 7RU

Other trials in United Kingdom

About this study

Official title: An Investigation Into the Acute Effects of Date Fruit (Phoenix Dactylifera L.) on Mood and Cognitive Performance in Healthy Volunteers.

A number of studies have considered the neuroprotective effects of date fruit on neurodegenerative diseases in animals. However, so far no study has addressed the acute effects of date fruit on mood and cognitive performance in humans. This study will investigate the acute effects of two different cultivars of Saudi dates on mood and cognitive performance into healthy volunteers.

This study will follow a double blind, randomised, placebo controlled, repeated measures, cross over design with two active treatment arms versus placebo. Treatment orders will be counterbalanced with the use of a Latin Square design.

Thirty six healthy participants aged between 18 and 35 will be recruited. Participants will be required to undergo a screening/training visit, followed by three measurement visits at weekly intervals. The trial will last for 3 months in total.

Read the detailed description

Introduction Fruit of the date palm (P. dactylifera) may be considered an emerging and potential candidate for the development of health-promoting foods owing to its high nutritive values (Juhaimi, Ghafoor et al. 2012). Recently, scientific studies have revealed the medicinal properties of P. dactylifera in the different ripening stages by examining anti-inflammatory, anti-angiogenic and antibacterial activity. The anti-inflammatory activity of various parts of P. dactylifera have been evaluated (Shabani, Zangiabadi et al. 2013); it is evident from these studies that, both in vivo and in vitro, date fruits display anti-inflammatory activity, strongly linked to secondary metabolites and antioxidant behaviour.

More than 16 published studies have investigated the physiological and the psychological effects of P. dactylifera on the brain using animal models. Although this domain of research is in its infancy , the findings are quite promising and suggest that date fruits have the potential to become, on the one hand, a neuroprotective agent in ischemic stroke (Majid, Marzieh et al. 2008), brain damage (Kalantaripour, Asadi-Shekaari et al. 2012), and Alzheimer's disease and (Essa, Akbar et al. 2016), on the other hand, a brain enhancer by attenuating impairment in cognition caused by neurodegenerative diseases (Subash, Essa et al. 2015).

Aim The aim of this study is to investigate the acute effects of two different cultivars of P. dactylifera commonly consumed in Saudi Arabia on mood and cognitive performance of healthy volunteers.

Design The project will investigate the acute effects on human cognitive function and mood after the administration of a single dose of two different date fruits using a yogurt as the carrier medium against a control yoghurt matched for sugar, flavour, volume, fibers, taste and appearance. The study will follow a double-blind, counterbalanced, placebo controlled, repeated measures design, with two active treatment arms versus placebo, with one week between each measurement visit. Treatment orders will be counterbalanced with the use of a Latin Square design (Williams 1949). Participants will be randomly allocated to a treatment order as selected through a Williams Latin Square. Participants will be required to undergo a screening/training visit, followed by three measurement visits at weekly intervals. The trial will last for 3 months in total, which is about 2-3 weeks for each participants.

Treatment Five different cultivars of date fruit were initially considered and screened for testing against cognitive performance and mood according to the following criteria; popularity, representation of the different maturation stages, and representation of the different colours, which has a great an effect on the total phenolic content. Therefore from the Bisir maturation stage Khasab and Birhi dates were chosen, from the Rutab maturation stage Sukari dates and Ajwah and Khalas dates were chosen from the Tamer maturation stage.

After a chemical analysis of polyphenol content of the five different cultivars, the study was narrowed down to two different cultivars of date fruits: Khasab and Birhi. According to our initial analysis Khasb and Birhi cultivars contained the highest amount of polyphenols, and while the total sugar in all varieties was similar it was lower in these two varieties compared with the others tested.

Taking the stickiness of the fruit and the high content of fibres, a total of 115g of date powder will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish® which has 240kJ/56kcal), with consideration to the wet weight variation prior to freeze drying process. The naturally occurring sugars in the date will be quantified. The total volume of the treatment yogurt will be up to 265 mg. The control yogurt will be a placebo mix containing glucose, fructose, sucrose, fibres and food dye in order to be closely matched for volume, taste, appearance, texture, and energy with the treatment. Yogurts will be coded and prepared freshly each morning by a third party who shall not take further part in the running of the study. No member of the investigation team will be aware of the coding of the drinks until a blind-data review is completed. Both the treatments and the placebo will be provided to the participants in plastic cups of similar appearance.

Participants A total of 36 healthy participants aged between 18 and 35 will be recruited through advertisement via poster and flyer. All participants will be required to undergo a screening visit.

Study procedures:

  1. Screening All participants will be screened for any contraindications prior to the beginning of the study. The eligible participants will then be asked to complete the Cog-Track Battery four times to remove practice effects. On each of the study days, cognitive assessments will be conducted at baseline, 45 min post dose, 90 min post dose and 135 min post dose. After completing each cognitive assessment, participants will be asked to complete Visual Analogue Scales to assess their mood status.
  2. Study day The volunteers will be briefed about the study protocol and will sign a written informed consent (see appendix). The participants will arrive at the NU-Food research center at about 9:30 am after a 12 hour overnight fast. Measurements of height and weight will be taken again in order to track any change, and this will be followed by a completion of the baseline Cog-Track Battery, Bond-Lader Visual Analogue Scales, Profile of mood states questionnaire and finger-prick blood glucose test. The participants will then consume their treatment for that day (as allocated by the Williams Latin square) and be asked to sit quietly (participants may work quietly, read or watch TV as they wish). They will be asked to start the second period of cognitive performance tasks 45 min after treatment administration to coincide with another blood glucose test. The same tasks (cognition and blood glucose) will be collected again at 90 min and 135 min post dose. Each of the three study visits will last approximately 3 hours. Participants will be required to stay in the research center during breaks between each test/blood sample. Participants will have access to a comfortable waiting room. At the end of the testing day all participants will receive a standard meal (A sandwich and a drink). (A detailed scheduling for screening and study days can be found in appendixes).
Being tested
Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute effect of two Saudi cultivars of date fruit on mood and cognitive performanceDietary supplement

    Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance at baseline, 45 post-dose, 90 min post-dose and 135 min post-dose

Study groups in NCT03350100
Study groupRoleWhat they receive
Birhi date cultivarExperimentalA 48.46 g of freeze dried powder of Birhi date Cultivar which is equivalent to a 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 162.8 mg/100 g of GAE. and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.
Receives: Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
Khassab date cultivarExperimentalA 34.5 g of freeze dried powder of Khassab date Cultivar which is equivalent to A 115g of fresh dates, contains 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and a total phenolic content of 91.52 mg/100 g of GAE. and 0.80 g of fibres,will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.
Receives: Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
placeboPlacebo comparatorA 14.72 g of total sugar in which 4.6 g Glucose, 2.49 fructose and 3.4 sucrose, and 0.80 g of fibres, will be mixed into one portion of low fat yogurt (e.g. Yeo yogurt 150 g BigFish®, which gives a total energy of 299 KJ.
Receives: Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognition: Simple Reaction Time

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  2. Cognition: Digit Vigilance

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  3. Cognition: Choice Reaction Time

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  4. Cognition: Numeric Working Memory

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  5. Cognition: Spatial Working Memory

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  6. Cognition: Immediate Word Recall

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  7. Cognition:Delayed Word Recall

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  8. Cognition:Word Recognition

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  9. Cognition:Pattern Separation

    Cog-track an online set of nine cognitive tests (www.wesnes.com).

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  10. Mood scales Bond Lader

    The Bond and Lader Visual Analogue Scales (1974)

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

  11. The Profile of Mood States (POMS)

    The Profile of Mood States (POMS; McNair et al., 1992)

    Measured: Change from visit 1 to visit 2 to visit 3

  12. Blood Glucose level test

    Finger prick

    Measured: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start31 Oct 2017
  3. Primary completion29 Mar 2018
  4. Study completion1 Apr 2018

Resources

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350100
Sponsor's protocol ID
DFCPM1
Status last verified
Sep 2018
First submitted
17 Nov 2017
Last updated
25 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance in people with Mood and Cognitive Performance, 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 11 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 25 Sep 2018. 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?

cognition: Simple Reaction Time (time frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose). The study lists 12 primary outcomes in all. 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 25 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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