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The Acute Effect of a Walnut Intervention on Cognitive Performance , Brain Activation, and Serum Markers of Inflammation in Young Adults (WallCog)

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ClinicalTrials.gov Identifier: NCT04075448
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborators:
California Walnut Commission
Tufts University
Information provided by (Responsible Party):
Prof Claire Williams, University of Reading

Brief Summary:
This study investigates the effect of acute walnut consumption on the cognitive behaviour, mood, brain activation, and markers of inflammation in young adults. In a within subjects design participants will receive a 50 g walnut or placebo intervention in a randomised order with a one week washout between interventions.

Condition or disease Intervention/treatment Phase
Cognitive Change Mood Inflammatory Response Brain Derived Neurotrophic Factor Level Satiety Other: Control Other: 50 g Walnut Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will be assigned to both the walnut and control conditions in a randomised order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be aware the possible contents of each treatment, however, neither the participants or investigators will be aware of which treatment the participants are receiving at the point of testing. All analysis will be performed in relation to a treatment code which will only be revealed once analysis is completed.
Primary Purpose: Basic Science
Official Title: The Acute Effect of a Walnut Intervention on Cognitive Performance , Brain Activation, and Serum Markers of Inflammation in Young Adults
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 31, 2020

Arm Intervention/treatment
Experimental: Control - 50g Walnut
Control condition followed by experimental condition.
Other: Control
100 grams breakfast cereal

Other: 50 g Walnut
50 grams walnuts mixed with 50 gram breakfast cereal.

Experimental: 50 g Walnut - Control
Experimental condition followed by control condition.
Other: Control
100 grams breakfast cereal

Other: 50 g Walnut
50 grams walnuts mixed with 50 gram breakfast cereal.




Primary Outcome Measures :
  1. Delayed Recall [ Time Frame: 2 hours following intervention. ]
    AVLT - Recall of a previously presented list of words following a 25 minute delay.

  2. Delayed Recall [ Time Frame: 4 hours following intervention. ]
    AVLT - Recall of a previously presented list of words following a 25 minute delay.

  3. Delayed Recall [ Time Frame: 6 hours following intervention. ]
    AVLT - Recall of a previously presented list of words following a 25 minute delay.

  4. Word Recognition [ Time Frame: 2 hours following intervention. ]
    AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  5. Word Recognition [ Time Frame: 4 hours following intervention. ]
    AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  6. Word Recognition [ Time Frame: 6 hours following intervention. ]
    AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  7. Response interference accuracy [ Time Frame: 2 hours following intervention. ]
    Accuracy performance on the Modified Attention Network Task

  8. Response interference accuracy [ Time Frame: 4 hours following intervention. ]
    Accuracy performance on the Modified Attention Network Task

  9. Response interference accuracy [ Time Frame: 6 hours following intervention. ]
    Accuracy performance on the Modified Attention Network Task

  10. Response interference reaction time [ Time Frame: 2 hours following intervention ]
    Reaction time performance on the Modified Attention Network Task

  11. Response interference reaction time [ Time Frame: 4 hours following intervention ]
    Reaction time performance on the Modified Attention Network Task

  12. Response interference reaction time [ Time Frame: 6 hours following intervention ]
    Reaction time performance on the Modified Attention Network Task

  13. Switching Task Accuracy [ Time Frame: 2 hours following intervention ]
    Accuracy performance on the switching task

  14. Switching Task Accuracy [ Time Frame: 4 hours following intervention ]
    Accuracy performance on the switching task

  15. Switching Task Accuracy [ Time Frame: 6 hours following intervention ]
    Accuracy performance on the switching task

  16. Switching Task reaction time [ Time Frame: 2 hours following intervention ]
    Reaction time performance on the switching task

  17. Switching Task reaction time [ Time Frame: 4 hours following intervention ]
    Reaction time performance on the switching task

  18. Switching Task reaction time [ Time Frame: 6 hours following intervention ]
    Reaction time performance on the switching task

  19. N2 [ Time Frame: 2 hours following intervention ]
    Change in ERP measure of N2 latency and amplitude

  20. N2 [ Time Frame: 4 hours following intervention ]
    Change in ERP measure of N2 latency and amplitude

  21. N2 [ Time Frame: 6 hours following intervention ]
    Change in ERP measure of N2 latency and amplitude

  22. P3 [ Time Frame: 2 hours following intervention ]
    Change in ERP measure of P3 latency and amplitude

  23. P3 [ Time Frame: 4 hours following intervention ]
    Change in ERP measure of P3 latency and amplitude

  24. P3 [ Time Frame: 6 hours following intervention ]
    Change in ERP measure of P3 latency and amplitude

  25. Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha. [ Time Frame: 2 hours following intervention ]
    Change in blood serum markers of inflammation

  26. Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha. [ Time Frame: 4 hours following intervention ]
    Change in blood serum markers of inflammation

  27. Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha. [ Time Frame: 6 hours following intervention ]
    Change in blood serum markers of inflammation

  28. BDNF [ Time Frame: 2 hours following intervention ]
    Change in blood serum levels of BDNF

  29. BDNF [ Time Frame: 4 hours following intervention ]
    Change in blood serum levels of BDNF

  30. BDNF [ Time Frame: 6 hours following intervention ]
    Change in blood serum levels of BDNF


Secondary Outcome Measures :
  1. Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000). [ Time Frame: 2 hours following intervention. ]
    Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger - taken as a positive outcome, less satiety - taken as a negative outcome, less fullness - taken as a negative outcome, and less desire for prospective food consumption - taken as a positive.

  2. Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000). [ Time Frame: 4 hours following intervention. ]
    Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger - taken as a positive outcome, less satiety - taken as a negative outcome, less fullness - taken as a negative outcome, and less desire for prospective food consumption - taken as a positive.

  3. Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000). [ Time Frame: 6 hours following intervention. ]
    Satiety Measure recorded on a 100 millimetre scale. Scores closer to 0 millimetres indicate less hunger - taken as a positive outcome, less satiety - taken as a negative outcome, less fullness - taken as a negative outcome, and less desire for prospective food consumption - taken as a positive.

  4. EEG Spectral Analysis. [ Time Frame: 2 hours following intervention. ]
    Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.

  5. EEG Spectral Analysis. [ Time Frame: 4 hours following intervention. ]
    Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.

  6. EEG Spectral Analysis. [ Time Frame: 6 hours following intervention. ]
    Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.

  7. Immediate Recall [ Time Frame: 2 hours following intervention ]
    AVLT - Immediate recall following first presentation of the word list

  8. Immediate Recall [ Time Frame: 4 hours following intervention ]
    AVLT - Immediate recall following first presentation of the word list

  9. Immediate Recall [ Time Frame: 6 hours following intervention ]
    AVLT - Immediate recall following first presentation of the word list

  10. Word Learning [ Time Frame: 2 hours following intervention ]
    AVLT - Area under the curve for first five word list recalls.

  11. Word Learning [ Time Frame: 4 hours following intervention ]
    AVLT - Area under the curve for first five word list recalls.

  12. Word Learning [ Time Frame: 6 hours following intervention ]
    AVLT - Area under the curve for first five word list recalls.

  13. Total Recall [ Time Frame: 2 hours following intervention. ]
    AVLT - Sum of first 5 word list recalls.

  14. Total Recall [ Time Frame: 4 hours following intervention. ]
    AVLT - Sum of first 5 word list recalls.

  15. Total Recall [ Time Frame: 6 hours following intervention. ]
    AVLT - Sum of first 5 word list recalls.

  16. Final Acquisition [ Time Frame: 2 hours following intervention ]
    AVLT - Immediate recall following final presentation of the word list

  17. Final Acquisition [ Time Frame: 4 hours following intervention ]
    AVLT - Immediate recall following final presentation of the word list

  18. Final Acquisition [ Time Frame: 6 hours following intervention ]
    AVLT - Immediate recall following final presentation of the word list

  19. Interference List Recall [ Time Frame: 2 hours following intervention. ]
    AVLT - Immediate recall of second (interference) list.

  20. Interference List Recall [ Time Frame: 4 hours following intervention. ]
    AVLT - Immediate recall of second (interference) list.

  21. Interference List Recall [ Time Frame: 6 hours following intervention. ]
    AVLT - Immediate recall of second (interference) list.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Normal or corrected hearing and vision

Exclusion Criteria:

  • Smoker.
  • Allergic to treatment contents.
  • Currently on medication which may interfere with the treatment
  • Anaemic

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): NCT04075448


Contacts
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Contact: Adrian R Whyte, PhD +44 (0)118 378 8523 ext 5563 a.r.whyte@reading.ac.uk
Contact: Lynne Bell, PhD +44 (0)118 378 8523 ext 5563 l.bell@reading.ac.uk

Locations
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United Kingdom
University of Reading Recruiting
Reading, Berkshire, United Kingdom, RG6 6AL
Contact: Claire M Williams, PhD    +44 (0) 118 378 7540    claire.williams@reading.ac.uk   
Contact: Sundus Khalid, MSc    +44 (0) 118 378 7928    Sundus.Khalid@pgr.reading.ac.uk   
Sponsors and Collaborators
University of Reading
California Walnut Commission
Tufts University
Investigators
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Principal Investigator: Claire M Williams, PhD University of Reading
Publications:

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Responsible Party: Prof Claire Williams, Chair of Neuroscience, University of Reading
ClinicalTrials.gov Identifier: NCT04075448    
Other Study ID Numbers: RDG-005
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The full dataset will be anonymized and made available on the University of Reading Research Data Archive.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be become available upon publication of study findings. Once published, the data will remain permanently available.
Access Criteria: The data will be Open Access and licensed as Creative Commons: Attribution 4.0

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof Claire Williams, University of Reading:
Flavonoid
Omega 3 Fatty Acid
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes