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Trial record 1 of 2 for:    phoenix dactylifera
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The Effect of Date Fruit on Mood and Cognition in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03350100
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Newcastle University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Mood and Cognitive Performance Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: An Investigation Into the Acute Effects of Date Fruit (Phoenix Dactylifera L.) on Mood and Cognitive Performance in Healthy Volunteers.
Actual Study Start Date : October 31, 2017
Actual Primary Completion Date : March 29, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Birhi date cultivar
A 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.
Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
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

Experimental: Khassab date cultivar
A 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.
Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
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

Placebo Comparator: placebo
A 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.
Dietary Supplement: Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance
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




Primary Outcome Measures :
  1. cognition: Simple Reaction Time [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  2. Cognition: Digit Vigilance [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  3. Cognition: Choice Reaction Time [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  4. Cognition: Numeric Working Memory [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  5. Cognition: Spatial Working Memory [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  6. Cognition: Immediate Word Recall [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  7. Cognition:Delayed Word Recall [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  8. Cognition:Word Recognition [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  9. Cognition:Pattern Separation [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Cog-track an online set of nine cognitive tests (www.wesnes.com).

  10. Mood scales Bond Lader [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    The Bond and Lader Visual Analogue Scales (1974)

  11. The Profile of Mood States (POMS) [ Time Frame: Change from visit 1 to visit 2 to visit 3 ]
    The Profile of Mood States (POMS; McNair et al., 1992)

  12. Blood Glucose level test [ Time Frame: Change from baseline, 45 min pos-dose, 90 min post-dose and 135 postdose ]
    Finger prick



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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:

  1. They have a BMI above 35kg/m2 or lower than 18kg/m2
  2. They smoke or consume tobacco products
  3. They are taking any illicit or prescribed drugs
  4. They are using dietary supplements, over the counter medicine or recreational drugs
  5. They have a history of or currently abuse alcohol
  6. They have a history of dyslexia, ADHD, learning difficulties or color blindness
  7. They are females who are pregnant, seeking to become pregnant or do not use
  8. They have allergies to any food products.
  9. They have any metabolic diseases such as type 1 or type 2 diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350100


Locations
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United Kingdom
NU-Food Research Facility
Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE1 7RU
Sponsors and Collaborators
Newcastle University
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Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03350100    
Other Study ID Numbers: DFCPM1
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No