Cognitive ChangeWalCogNCT04075448
The Acute Effect of a Walnut Intervention on Cognitive Performance, Brain Activation, and Serum Markers of Inflammation in Young Adults
A study testing 50 g Walnut in people with Cognitive Change and Mood, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Mood, Inflammatory Response
- What is being tested?
- 50 g Walnut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2019to 30 Oct 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Normal or corrected hearing and vision
Who cannot join
- Smoker.
- Allergic to treatment contents.
- Currently on medication which may interfere with the treatment
- Anaemic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of a Walnut Intervention on Cognitive Performance , Brain Activation, and Serum Markers of Inflammation in Young Adults
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.
Read the 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.
- Conditions
- Cognitive Change, Mood, Inflammatory Response, Brain Derived Neurotrophic Factor Level, Satiety
- Being tested
- Control, 50 g Walnut
- Keywords
- Flavonoid, Omega 3 Fatty Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
100 grams breakfast cereal
50 g WalnutOther
50 grams walnuts mixed with 50 gram breakfast cereal.
| Study group | Role | What they receive |
|---|---|---|
| Control - 50g Walnut | Experimental | Control condition followed by experimental condition. Receives: Other: Control; Other: 50 g Walnut |
| 50 g Walnut - Control | Experimental | Experimental condition followed by control condition. Receives: Other: Control; Other: 50 g Walnut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Measured: 2 hours following intervention.
Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Measured: 4 hours following intervention.
Delayed Recall
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Measured: 6 hours following intervention.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Measured: 2 hours following intervention.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Measured: 4 hours following intervention.
Word Recognition
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Measured: 6 hours following intervention.
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Measured: 2 hours following intervention.
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Measured: 4 hours following intervention.
Response interference accuracy
Accuracy performance on the Modified Attention Network Task
Measured: 6 hours following intervention.
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Measured: 2 hours following intervention
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Measured: 4 hours following intervention
Response interference reaction time
Reaction time performance on the Modified Attention Network Task
Measured: 6 hours following intervention
Switching Task Accuracy
Accuracy performance on the switching task
Measured: 2 hours following intervention
Switching Task Accuracy
Accuracy performance on the switching task
Measured: 4 hours following intervention
Switching Task Accuracy
Accuracy performance on the switching task
Measured: 6 hours following intervention
Switching Task reaction time
Reaction time performance on the switching task
Measured: 2 hours following intervention
Switching Task reaction time
Reaction time performance on the switching task
Measured: 4 hours following intervention
Switching Task reaction time
Reaction time performance on the switching task
Measured: 6 hours following intervention
N2
Change in ERP measure of N2 latency and amplitude
Measured: 2 hours following intervention
N2
Change in ERP measure of N2 latency and amplitude
Measured: 4 hours following intervention
N2
Change in ERP measure of N2 latency and amplitude
Measured: 6 hours following intervention
P3
Change in ERP measure of P3 latency and amplitude
Measured: 2 hours following intervention
P3
Change in ERP measure of P3 latency and amplitude
Measured: 4 hours following intervention
P3
Change in ERP measure of P3 latency and amplitude
Measured: 6 hours following intervention
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
Measured: 2 hours following intervention
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
Measured: 4 hours following intervention
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
Measured: 6 hours following intervention
BDNF
Change in blood serum levels of BDNF
Measured: 2 hours following intervention
BDNF
Change in blood serum levels of BDNF
Measured: 4 hours following intervention
BDNF
Change in blood serum levels of BDNF
Measured: 6 hours following intervention
Secondary outcomes (21)
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.
Measured: 2 hours following intervention.
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.
Measured: 4 hours following intervention.
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.
Measured: 6 hours following intervention.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Measured: 2 hours following intervention.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Measured: 4 hours following intervention.
EEG Spectral Analysis.
Changes in Power for Alpha, Beta, Gamma, Delta, and Theta bands during performance of each cognitive task.
Measured: 6 hours following intervention.
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Measured: 2 hours following intervention
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Measured: 4 hours following intervention
Immediate Recall
AVLT - Immediate recall following first presentation of the word list
Measured: 6 hours following intervention
Word Learning
AVLT - Area under the curve for first five word list recalls.
Measured: 2 hours following intervention
Word Learning
AVLT - Area under the curve for first five word list recalls.
Measured: 4 hours following intervention
Word Learning
AVLT - Area under the curve for first five word list recalls.
Measured: 6 hours following intervention
Total Recall
AVLT - Sum of first 5 word list recalls.
Measured: 2 hours following intervention.
Total Recall
AVLT - Sum of first 5 word list recalls.
Measured: 4 hours following intervention.
Total Recall
AVLT - Sum of first 5 word list recalls.
Measured: 6 hours following intervention.
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Measured: 2 hours following intervention
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Measured: 4 hours following intervention
Final Acquisition
AVLT - Immediate recall following final presentation of the word list
Measured: 6 hours following intervention
Interference List Recall
AVLT - Immediate recall of second (interference) list.
Measured: 2 hours following intervention.
Interference List Recall
AVLT - Immediate recall of second (interference) list.
Measured: 4 hours following intervention.
Interference List Recall
AVLT - Immediate recall of second (interference) list.
Measured: 6 hours following intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start8 Nov 2019
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be assigned to both the walnut and control conditions in a randomised order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission, Tufts University
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire M Williams, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075448
- Sponsor's protocol ID
- RDG-005
- Acronym
- WalCog
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2019
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full dataset will be anonymized and made available on the University of Reading Research Data Archive.
Publications
Bell L, Lamport DJ, Butler LT, Williams CM. A Review of the Cognitive Effects Observed in Humans Following Acute Supplementation with Flavonoids, and Their Associated Mechanisms of Action. Nutrients. 2015 Dec 9;7(12):10290-306. doi: 10.3390/nu7125538.
PubMed 26690214Carey AN, Fisher DR, Joseph JA, Shukitt-Hale B. The ability of walnut extract and fatty acids to protect against the deleterious effects of oxidative stress and inflammation in hippocampal cells. Nutr Neurosci. 2013 Jan;16(1):13-20. doi: 10.1179/1476830512Y.0000000023. Epub 2012 Dec 4.
PubMed 23321679Fisher DR, Poulose SM, Bielinski DF, Shukitt-Hale B. Serum metabolites from walnut-fed aged rats attenuate stress-induced neurotoxicity in BV-2 microglial cells. Nutr Neurosci. 2017 Feb;20(2):103-109. doi: 10.1179/1476830514Y.0000000150. Epub 2016 Mar 2.
PubMed 25153536Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.
PubMed 18568016Haider S, Batool Z, Tabassum S, Perveen T, Saleem S, Naqvi F, Javed H, Haleem DJ. Effects of walnuts (Juglans regia) on learning and memory functions. Plant Foods Hum Nutr. 2011 Nov;66(4):335-40. doi: 10.1007/s11130-011-0260-2.
PubMed 22048906Martinez-Lapiscina EH, Clavero P, Toledo E, Estruch R, Salas-Salvado J, San Julian B, Sanchez-Tainta A, Ros E, Valls-Pedret C, Martinez-Gonzalez MA. Mediterranean diet improves cognition: the PREDIMED-NAVARRA randomised trial. J Neurol Neurosurg Psychiatry. 2013 Dec;84(12):1318-25. doi: 10.1136/jnnp-2012-304792. Epub 2013 May 13.
PubMed 23670794Miller MG, Thangthaeng N, Poulose SM, Shukitt-Hale B. Role of fruits, nuts, and vegetables in maintaining cognitive health. Exp Gerontol. 2017 Aug;94:24-28. doi: 10.1016/j.exger.2016.12.014. Epub 2016 Dec 21.
PubMed 28011241Nooyens AC, Bueno-de-Mesquita HB, van Boxtel MP, van Gelder BM, Verhagen H, Verschuren WM. Fruit and vegetable intake and cognitive decline in middle-aged men and women: the Doetinchem Cohort Study. Br J Nutr. 2011 Sep;106(5):752-61. doi: 10.1017/S0007114511001024. Epub 2011 Apr 11.
PubMed 21477405O'Brien J, Okereke O, Devore E, Rosner B, Breteler M, Grodstein F. Long-term intake of nuts in relation to cognitive function in older women. J Nutr Health Aging. 2014 May;18(5):496-502. doi: 10.1007/s12603-014-0014-6.
PubMed 24886736Perez-Cano FJ, Castell M. Flavonoids, Inflammation and Immune System. Nutrients. 2016 Oct 21;8(10):659. doi: 10.3390/nu8100659.
PubMed 27775647Poulose SM, Bielinski DF, Shukitt-Hale B. Walnut diet reduces accumulation of polyubiquitinated proteins and inflammation in the brain of aged rats. J Nutr Biochem. 2013 May;24(5):912-9. doi: 10.1016/j.jnutbio.2012.06.009. Epub 2012 Aug 20.
PubMed 22917841Pribis P, Bailey RN, Russell AA, Kilsby MA, Hernandez M, Craig WJ, Grajales T, Shavlik DJ, Sabate J. Effects of walnut consumption on cognitive performance in young adults. Br J Nutr. 2012 May;107(9):1393-401. doi: 10.1017/S0007114511004302. Epub 2011 Sep 19.
PubMed 21923981Ros E, Hu FB. Consumption of plant seeds and cardiovascular health: epidemiological and clinical trial evidence. Circulation. 2013 Jul 30;128(5):553-65. doi: 10.1161/CIRCULATIONAHA.112.001119. No abstract available.
PubMed 23897849Sanchez-Villegas A, Galbete C, Martinez-Gonzalez MA, Martinez JA, Razquin C, Salas-Salvado J, Estruch R, Buil-Cosiales P, Marti A. The effect of the Mediterranean diet on plasma brain-derived neurotrophic factor (BDNF) levels: the PREDIMED-NAVARRA randomized trial. Nutr Neurosci. 2011 Sep;14(5):195-201. doi: 10.1179/1476830511Y.0000000011.
PubMed 22005283Valls-Pedret C, Sala-Vila A, Serra-Mir M, Corella D, de la Torre R, Martinez-Gonzalez MA, Martinez-Lapiscina EH, Fito M, Perez-Heras A, Salas-Salvado J, Estruch R, Ros E. Mediterranean Diet and Age-Related Cognitive Decline: A Randomized Clinical Trial. JAMA Intern Med. 2015 Jul;175(7):1094-1103. doi: 10.1001/jamainternmed.2015.1668.
PubMed 25961184
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of a Walnut Intervention on Cognitive Performance , Brain Activation, and Serum Markers of Inflammation in Young Adults
- ClinicalTrials.gov ID
- NCT04075448
- Acronym / sponsor ID
- WalCog / RDG-005
- Conditions
- Cognitive Change, Mood, Inflammatory Response, Brain Derived Neurotrophic Factor Level, Satiety
- Keywords
- Flavonoid, Omega 3 Fatty Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- California Walnut Commission, Tufts University
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to both the walnut and control conditions in a randomised order.
| Arm | Type | Receives |
|---|---|---|
| Control - 50g Walnut | Experimental | Other: Control, Other: 50 g WalnutControl condition followed by experimental condition. |
| 50 g Walnut - Control | Experimental | Other: Control, Other: 50 g WalnutExperimental condition followed by control condition. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Normal or corrected hearing and vision
Key exclusion criteria (4 listed)
- Smoker.
- Allergic to treatment contents.
- Currently on medication which may interfere with the treatment
- Anaemic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control100 grams breakfast cereal | Other | 50 g Walnut - Control, Control - 50g Walnut |
| 50 g Walnut50 grams walnuts mixed with 50 gram breakfast cereal. | Other | 50 g Walnut - Control, Control - 50g Walnut |
Primary outcome
Delayed Recall
Time frame: 2 hours following intervention.
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Delayed Recall
Time frame: 4 hours following intervention.
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Delayed Recall
Time frame: 6 hours following intervention.
AVLT - Recall of a previously presented list of words following a 25 minute delay.
Word Recognition
Time frame: 2 hours following intervention.
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Word Recognition
Time frame: 4 hours following intervention.
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Word Recognition
Time frame: 6 hours following intervention.
AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.
Response interference accuracy
Time frame: 2 hours following intervention.
Accuracy performance on the Modified Attention Network Task
Response interference accuracy
Time frame: 4 hours following intervention.
Accuracy performance on the Modified Attention Network Task
Response interference accuracy
Time frame: 6 hours following intervention.
Accuracy performance on the Modified Attention Network Task
Response interference reaction time
Time frame: 2 hours following intervention
Reaction time performance on the Modified Attention Network Task
Response interference reaction time
Time frame: 4 hours following intervention
Reaction time performance on the Modified Attention Network Task
Response interference reaction time
Time frame: 6 hours following intervention
Reaction time performance on the Modified Attention Network Task
Switching Task Accuracy
Time frame: 2 hours following intervention
Accuracy performance on the switching task
Switching Task Accuracy
Time frame: 4 hours following intervention
Accuracy performance on the switching task
Switching Task Accuracy
Time frame: 6 hours following intervention
Accuracy performance on the switching task
Switching Task reaction time
Time frame: 2 hours following intervention
Reaction time performance on the switching task
Switching Task reaction time
Time frame: 4 hours following intervention
Reaction time performance on the switching task
Switching Task reaction time
Time frame: 6 hours following intervention
Reaction time performance on the switching task
N2
Time frame: 2 hours following intervention
Change in ERP measure of N2 latency and amplitude
N2
Time frame: 4 hours following intervention
Change in ERP measure of N2 latency and amplitude
N2
Time frame: 6 hours following intervention
Change in ERP measure of N2 latency and amplitude
P3
Time frame: 2 hours following intervention
Change in ERP measure of P3 latency and amplitude
P3
Time frame: 4 hours following intervention
Change in ERP measure of P3 latency and amplitude
P3
Time frame: 6 hours following intervention
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.
Time frame: 2 hours following intervention
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.
Time frame: 4 hours following intervention
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.
Time frame: 6 hours following intervention
Change in blood serum markers of inflammation
BDNF
Time frame: 2 hours following intervention
Change in blood serum levels of BDNF
BDNF
Time frame: 4 hours following intervention
Change in blood serum levels of BDNF
BDNF
Time frame: 6 hours following intervention
Change in blood serum levels of BDNF
21 secondary outcomes
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Time frame: 2 hours following intervention.
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Time frame: 4 hours following intervention.
Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).
Time frame: 6 hours following intervention.
EEG Spectral Analysis.
Time frame: 2 hours following intervention.
EEG Spectral Analysis.
Time frame: 4 hours following intervention.
EEG Spectral Analysis.
Time frame: 6 hours following intervention.
Immediate Recall
Time frame: 2 hours following intervention
Immediate Recall
Time frame: 4 hours following intervention
Immediate Recall
Time frame: 6 hours following intervention
Word Learning
Time frame: 2 hours following intervention
Word Learning
Time frame: 4 hours following intervention
Word Learning
Time frame: 6 hours following intervention
Total Recall
Time frame: 2 hours following intervention.
Total Recall
Time frame: 4 hours following intervention.
Total Recall
Time frame: 6 hours following intervention.
Final Acquisition
Time frame: 2 hours following intervention
Final Acquisition
Time frame: 4 hours following intervention
Final Acquisition
Time frame: 6 hours following intervention
Interference List Recall
Time frame: 2 hours following intervention.
Interference List Recall
Time frame: 4 hours following intervention.
Interference List Recall
Time frame: 6 hours following intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Background: PubMed 26690214Bell L, Lamport DJ, Butler LT, Williams CM. A Review of the Cognitive Effects Observed in Humans Following Acute Supplementation with Flavonoids, and Their Associated Mechanisms of Action. Nutrients. 2015 Dec 9;7(12):10290-306. doi: 10.3390/nu7125538.
- Background: PubMed 23321679Carey AN, Fisher DR, Joseph JA, Shukitt-Hale B. The ability of walnut extract and fatty acids to protect against the deleterious effects of oxidative stress and inflammation in hippocampal cells. Nutr Neurosci. 2013 Jan;16(1):13-20. doi: 10.1179/1476830512Y.0000000023. Epub 2012 Dec 4.
- Background: PubMed 25153536Fisher DR, Poulose SM, Bielinski DF, Shukitt-Hale B. Serum metabolites from walnut-fed aged rats attenuate stress-induced neurotoxicity in BV-2 microglial cells. Nutr Neurosci. 2017 Feb;20(2):103-109. doi: 10.1179/1476830514Y.0000000150. Epub 2016 Mar 2.
- Background: PubMed 18568016Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.
- Background: PubMed 22048906Haider S, Batool Z, Tabassum S, Perveen T, Saleem S, Naqvi F, Javed H, Haleem DJ. Effects of walnuts (Juglans regia) on learning and memory functions. Plant Foods Hum Nutr. 2011 Nov;66(4):335-40. doi: 10.1007/s11130-011-0260-2.
- Background: PubMed 23670794Martinez-Lapiscina EH, Clavero P, Toledo E, Estruch R, Salas-Salvado J, San Julian B, Sanchez-Tainta A, Ros E, Valls-Pedret C, Martinez-Gonzalez MA. Mediterranean diet improves cognition: the PREDIMED-NAVARRA randomised trial. J Neurol Neurosurg Psychiatry. 2013 Dec;84(12):1318-25. doi: 10.1136/jnnp-2012-304792. Epub 2013 May 13.
- Background: PubMed 28011241Miller MG, Thangthaeng N, Poulose SM, Shukitt-Hale B. Role of fruits, nuts, and vegetables in maintaining cognitive health. Exp Gerontol. 2017 Aug;94:24-28. doi: 10.1016/j.exger.2016.12.014. Epub 2016 Dec 21.
- Background: PubMed 21477405Nooyens AC, Bueno-de-Mesquita HB, van Boxtel MP, van Gelder BM, Verhagen H, Verschuren WM. Fruit and vegetable intake and cognitive decline in middle-aged men and women: the Doetinchem Cohort Study. Br J Nutr. 2011 Sep;106(5):752-61. doi: 10.1017/S0007114511001024. Epub 2011 Apr 11.
- Background: PubMed 24886736O'Brien J, Okereke O, Devore E, Rosner B, Breteler M, Grodstein F. Long-term intake of nuts in relation to cognitive function in older women. J Nutr Health Aging. 2014 May;18(5):496-502. doi: 10.1007/s12603-014-0014-6.
- Background: PubMed 27775647Perez-Cano FJ, Castell M. Flavonoids, Inflammation and Immune System. Nutrients. 2016 Oct 21;8(10):659. doi: 10.3390/nu8100659.
- Background: PubMed 22917841Poulose SM, Bielinski DF, Shukitt-Hale B. Walnut diet reduces accumulation of polyubiquitinated proteins and inflammation in the brain of aged rats. J Nutr Biochem. 2013 May;24(5):912-9. doi: 10.1016/j.jnutbio.2012.06.009. Epub 2012 Aug 20.
- Background: PubMed 21923981Pribis P, Bailey RN, Russell AA, Kilsby MA, Hernandez M, Craig WJ, Grajales T, Shavlik DJ, Sabate J. Effects of walnut consumption on cognitive performance in young adults. Br J Nutr. 2012 May;107(9):1393-401. doi: 10.1017/S0007114511004302. Epub 2011 Sep 19.
- Individual participant dataSharing planned: Yes. The full dataset will be anonymized and made available on the University of Reading Research Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire M Williams, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50 g Walnut in people with Cognitive Change and Mood, run by University of Reading 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 2 inclusion and 4 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 20 Aug 2021. 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. 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?
Delayed Recall (time frame: 2 hours following intervention.). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075448, which also lists 17 linked publications.
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 20 Aug 2021.