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

Primary Purpose

Cognitive Change, Mood, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control
50 g Walnut
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cognitive Change focused on measuring Flavonoid, Omega 3 Fatty Acid

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control - 50g Walnut

50 g Walnut - Control

Arm Description

Control condition followed by experimental condition.

Experimental condition followed by control condition.

Outcomes

Primary Outcome Measures

Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Switching Task Accuracy
Accuracy performance on the switching task
Switching Task Accuracy
Accuracy performance on the switching task
Switching Task Accuracy
Accuracy performance on the switching task
Switching Task reaction time
Reaction time performance on the switching task
Switching Task reaction time
Reaction time performance on the switching task
Switching Task reaction time
Reaction time performance on the switching task
N2
Change in ERP measure of N2 latency and amplitude
N2
Change in ERP measure of N2 latency and amplitude
N2
Change in ERP measure of N2 latency and amplitude
P3
Change in ERP measure of P3 latency and amplitude
P3
Change in ERP measure of P3 latency and amplitude
P3
Change in ERP measure of P3 latency and amplitude
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Change in blood serum markers of inflammation
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Change in blood serum markers of inflammation
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Change in blood serum markers of inflammation
BDNF
Change in blood serum levels of BDNF
BDNF
Change in blood serum levels of BDNF
BDNF
Change in blood serum levels of BDNF

Secondary Outcome Measures

Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
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.
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
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.
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
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.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Word Learning
AVLT - Area under the curve for first five word list recalls.
Word Learning
AVLT - Area under the curve for first five word list recalls.
Word Learning
AVLT - Area under the curve for first five word list recalls.
Total Recall
AVLT - Sum of first 5 word list recalls.
Total Recall
AVLT - Sum of first 5 word list recalls.
Total Recall
AVLT - Sum of first 5 word list recalls.
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Interference List Recall
AVLT - Immediate recall of second (interference) list.
Interference List Recall
AVLT - Immediate recall of second (interference) list.
Interference List Recall
AVLT - Immediate recall of second (interference) list.

Full Information

First Posted
August 7, 2019
Last Updated
August 16, 2021
Sponsor
University of Reading
Collaborators
California Walnut Commission, Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT04075448
Brief Title
The Acute Effect of a Walnut Intervention on Cognitive Performance, Brain Activation, and Serum Markers of Inflammation in Young Adults
Acronym
WalCog
Official Title
The Acute Effect of a Walnut Intervention on Cognitive Performance , Brain Activation, and Serum Markers of Inflammation in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
California Walnut Commission, Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Participants will attend two test session days separated by a 7 day wash out period. The procedure on each day will be identical save for the intervention breakfast which will either be a walnut rich muesli containing 50g walnut and 50g mixed cereal ingredients (active intervention), or control muesli containing 100g mixed cereal ingredients (placebo intervention). The order of intervention will be randomised such that 50% of participants receive the active intervention during visit 1 and 50% during visit 2. Participants will be required to follow a low flavonoid diet for 48 hours in advance of testing and to fast (water only) for the final 12 hours of this period. The test day will be 8hrs in total starting at 0830. Cognitive Measures: There will be four cognitive task battery sessions taking place at baseline, then 2, 4, and 6 hours following intervention. The cognitive battery will last for 30 minutes and include: Auditory Verbal Learning Task (AVLT) - Participants hear and recall a list of 15 words on 8 occasions followed by a forced choice visual recognition task (10 minutes duration). Modified Attention Network Task (MANT) - Participants view different arrays of arrows displayed on a monitor and respond by indicating the direction of the arrow closest to a central fixation point (8 minutes duration). Switching Task - Participants view eight equally spaced radii of circle displayed in such a way that there are four equally spaced segments above and below a bold line. Stimulus digits selected from between 1 - 9 (excluding 5) appear in each segment in turn. Participants respond to digits above the bold line in terms of whether they are odd or even and below the bold line in terms of whether they are above or below the number 5 (10 minutes duration). PANAS-NOW - This measure of trait mood will be completed at the beginning and end of each task battery giving a total of 8 measurements across the day. Participants rate the extent to which they are experiencing 20 different emotions on a 5-point Likert scale ranging from 'very slightly' to 'very much' (1 minute duration). EEG: All participants will be tested in our dedicated lab within the Reading University Centre for Integrative Neuroscience and Neurodynamics using the Brain Products EEG system with 32 channel active electrode caps. At Baseline, 2, 4 and 6 hrs waveband PSD data will be recorded during all tasks with specific attention being paid to the theta bandwidth during the AVLT and gamma bandwidth during the executive function tasks. ERP data, anchored to each trial of the executive function tasks, will also be considered with specific attention being given to latency and strength of N1 and P3 peaks. Bloods: Participants will have bloods taken twice on each test visit with a draw being taken from each arm. The initial draw will be taken immediately prior to the baseline task battery and then immediately prior to either the 2, 4 or 6 hr session with the second draw time being randomised in such a way that 16 participants will have blood drawn at 2hrs, 16 at 4hrs, and 16 at 6hrs. Following each draw, the blood samples will be left to clot for 30-60 minutes. The serum will be separated via centrifuge and stored at at -80°C until analysis is complete. Whole blood samples will not be stored at any point during the study. Blood serum will be analysed for anti-inflammatory ability, as well as levels of BDNF, a signalling protein known to be positively related to memory function. To determine possible mechanisms of action of walnut components through which the walnut polyphenols produce their beneficial effects, microglial cells from rats will be exposed to serum from participants in both walnut and placebo conditions prior to exposure to an inflammatory challenge (LPS). Markers of inflammation will then be assessed including extracellular release of nitric oxide (NO) and tumor necrosis factor-alpha (TNF-α) as well as intracellular levels of inducible nitrous oxide synthase (iNOS) and cyclooxygenase-2 (COX-2). We will then determine if those subjects with the most protective serum in the cell model are those with the better cognitive performance. Appetite Measures: Ratings of subjective appetite and fullness will be taken using visual analogue scales after baseline, breakfast, and each of the remaining test sessions. As a further measure of satiety, weighted food measurements will be taken before and after consumption of the standard low flavonoid/PUFA lunch (given immediately after task battery session 3 at 1330) to ascertain total food consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Change, Mood, Inflammatory Response, Brain Derived Neurotrophic Factor Level, Satiety
Keywords
Flavonoid, Omega 3 Fatty Acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will be assigned to both the walnut and control conditions in a randomised order.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - 50g Walnut
Arm Type
Experimental
Arm Description
Control condition followed by experimental condition.
Arm Title
50 g Walnut - Control
Arm Type
Experimental
Arm Description
Experimental condition followed by control condition.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
100 grams breakfast cereal
Intervention Type
Other
Intervention Name(s)
50 g Walnut
Intervention Description
50 grams walnuts mixed with 50 gram breakfast cereal.
Primary Outcome Measure Information:
Title
Delayed Recall
Description
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Time Frame
2 hours following intervention.
Title
Delayed Recall
Description
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Time Frame
4 hours following intervention.
Title
Delayed Recall
Description
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Time Frame
6 hours following intervention.
Title
Word Recognition
Description
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Time Frame
2 hours following intervention.
Title
Word Recognition
Description
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Time Frame
4 hours following intervention.
Title
Word Recognition
Description
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Time Frame
6 hours following intervention.
Title
Response interference accuracy
Description
Accuracy performance on the Modified Attention Network Task
Time Frame
2 hours following intervention.
Title
Response interference accuracy
Description
Accuracy performance on the Modified Attention Network Task
Time Frame
4 hours following intervention.
Title
Response interference accuracy
Description
Accuracy performance on the Modified Attention Network Task
Time Frame
6 hours following intervention.
Title
Response interference reaction time
Description
Reaction time performance on the Modified Attention Network Task
Time Frame
2 hours following intervention
Title
Response interference reaction time
Description
Reaction time performance on the Modified Attention Network Task
Time Frame
4 hours following intervention
Title
Response interference reaction time
Description
Reaction time performance on the Modified Attention Network Task
Time Frame
6 hours following intervention
Title
Switching Task Accuracy
Description
Accuracy performance on the switching task
Time Frame
2 hours following intervention
Title
Switching Task Accuracy
Description
Accuracy performance on the switching task
Time Frame
4 hours following intervention
Title
Switching Task Accuracy
Description
Accuracy performance on the switching task
Time Frame
6 hours following intervention
Title
Switching Task reaction time
Description
Reaction time performance on the switching task
Time Frame
2 hours following intervention
Title
Switching Task reaction time
Description
Reaction time performance on the switching task
Time Frame
4 hours following intervention
Title
Switching Task reaction time
Description
Reaction time performance on the switching task
Time Frame
6 hours following intervention
Title
N2
Description
Change in ERP measure of N2 latency and amplitude
Time Frame
2 hours following intervention
Title
N2
Description
Change in ERP measure of N2 latency and amplitude
Time Frame
4 hours following intervention
Title
N2
Description
Change in ERP measure of N2 latency and amplitude
Time Frame
6 hours following intervention
Title
P3
Description
Change in ERP measure of P3 latency and amplitude
Time Frame
2 hours following intervention
Title
P3
Description
Change in ERP measure of P3 latency and amplitude
Time Frame
4 hours following intervention
Title
P3
Description
Change in ERP measure of P3 latency and amplitude
Time Frame
6 hours following intervention
Title
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Description
Change in blood serum markers of inflammation
Time Frame
2 hours following intervention
Title
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Description
Change in blood serum markers of inflammation
Time Frame
4 hours following intervention
Title
Inflammatory Measure of nitrous oxide, tumor necorsis factor-alpha, inducible nitrous oxide synthase, and tumor necrosis facor-alpha.
Description
Change in blood serum markers of inflammation
Time Frame
6 hours following intervention
Title
BDNF
Description
Change in blood serum levels of BDNF
Time Frame
2 hours following intervention
Title
BDNF
Description
Change in blood serum levels of BDNF
Time Frame
4 hours following intervention
Title
BDNF
Description
Change in blood serum levels of BDNF
Time Frame
6 hours following intervention
Secondary Outcome Measure Information:
Title
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Description
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.
Time Frame
2 hours following intervention.
Title
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Description
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.
Time Frame
4 hours following intervention.
Title
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Description
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.
Time Frame
6 hours following intervention.
Title
EEG Spectral Analysis.
Description
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Time Frame
2 hours following intervention.
Title
EEG Spectral Analysis.
Description
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Time Frame
4 hours following intervention.
Title
EEG Spectral Analysis.
Description
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Time Frame
6 hours following intervention.
Title
Immediate Recall
Description
AVLT - Immediate recall following first presentation of the word list
Time Frame
2 hours following intervention
Title
Immediate Recall
Description
AVLT - Immediate recall following first presentation of the word list
Time Frame
4 hours following intervention
Title
Immediate Recall
Description
AVLT - Immediate recall following first presentation of the word list
Time Frame
6 hours following intervention
Title
Word Learning
Description
AVLT - Area under the curve for first five word list recalls.
Time Frame
2 hours following intervention
Title
Word Learning
Description
AVLT - Area under the curve for first five word list recalls.
Time Frame
4 hours following intervention
Title
Word Learning
Description
AVLT - Area under the curve for first five word list recalls.
Time Frame
6 hours following intervention
Title
Total Recall
Description
AVLT - Sum of first 5 word list recalls.
Time Frame
2 hours following intervention.
Title
Total Recall
Description
AVLT - Sum of first 5 word list recalls.
Time Frame
4 hours following intervention.
Title
Total Recall
Description
AVLT - Sum of first 5 word list recalls.
Time Frame
6 hours following intervention.
Title
Final Acquisition
Description
AVLT - Immediate recall following final presentation of the word list
Time Frame
2 hours following intervention
Title
Final Acquisition
Description
AVLT - Immediate recall following final presentation of the word list
Time Frame
4 hours following intervention
Title
Final Acquisition
Description
AVLT - Immediate recall following final presentation of the word list
Time Frame
6 hours following intervention
Title
Interference List Recall
Description
AVLT - Immediate recall of second (interference) list.
Time Frame
2 hours following intervention.
Title
Interference List Recall
Description
AVLT - Immediate recall of second (interference) list.
Time Frame
4 hours following intervention.
Title
Interference List Recall
Description
AVLT - Immediate recall of second (interference) list.
Time Frame
6 hours following intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire M Williams, PhD
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The full dataset will be anonymized and made available on the University of Reading Research Data Archive.
IPD Sharing Time Frame
Data will be become available upon publication of study findings. Once published, the data will remain permanently available.
IPD Sharing Access Criteria
The data will be Open Access and licensed as Creative Commons: Attribution 4.0
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The Acute Effect of a Walnut Intervention on Cognitive Performance, Brain Activation, and Serum Markers of Inflammation in Young Adults

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