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

NCT04075448 | Completed

• 1 other identifier: RDG-005
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Mood; Inflammatory Response; Brain Derived Neurotrophic Factor Level; Satiety

Keywords

Flavonoid; Omega 3 Fatty Acid

Outcome Measures

Primary Outcomes (30)

• Delayed Recall

  AVLT - Recall of a previously presented list of words following a 25 minute delay.

  2 hours following intervention.

• Delayed Recall

  AVLT - Recall of a previously presented list of words following a 25 minute delay.

  4 hours following intervention.

• Delayed Recall

  AVLT - Recall of a previously presented list of words following a 25 minute delay.

  6 hours following intervention.

• Word Recognition

  AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  2 hours following intervention.

• Word Recognition

  AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  4 hours following intervention.

• Word Recognition

  AVLT - Visual Recognition of a previously presented list of words following a 25 minute delay.

  6 hours following intervention.

• Response interference accuracy

  Accuracy performance on the Modified Attention Network Task

  2 hours following intervention.

• Response interference accuracy

  Accuracy performance on the Modified Attention Network Task

  4 hours following intervention.

• Response interference accuracy

  Accuracy performance on the Modified Attention Network Task

  6 hours following intervention.

• Response interference reaction time

  Reaction time performance on the Modified Attention Network Task

  2 hours following intervention

• Response interference reaction time

  Reaction time performance on the Modified Attention Network Task

  4 hours following intervention

• Response interference reaction time

  Reaction time performance on the Modified Attention Network Task

  6 hours following intervention

• Switching Task Accuracy

  Accuracy performance on the switching task

  2 hours following intervention

• Switching Task Accuracy

  Accuracy performance on the switching task

  4 hours following intervention

• Switching Task Accuracy

  Accuracy performance on the switching task

  6 hours following intervention

• Switching Task reaction time

  Reaction time performance on the switching task

  2 hours following intervention

• Switching Task reaction time

  Reaction time performance on the switching task

  4 hours following intervention

• Switching Task reaction time

  Reaction time performance on the switching task

  6 hours following intervention

• N2

  Change in ERP measure of N2 latency and amplitude

  2 hours following intervention

• N2

  Change in ERP measure of N2 latency and amplitude

  4 hours following intervention

• N2

  Change in ERP measure of N2 latency and amplitude

  6 hours following intervention

• P3

  Change in ERP measure of P3 latency and amplitude

  2 hours following intervention

• P3

  Change in ERP measure of P3 latency and amplitude

  4 hours following intervention

• P3

  Change in ERP measure of P3 latency and amplitude

  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

  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

  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

  6 hours following intervention

• BDNF

  Change in blood serum levels of BDNF

  2 hours following intervention

• BDNF

  Change in blood serum levels of BDNF

  4 hours following intervention

• BDNF

  Change in blood serum levels of BDNF

  6 hours following intervention

Secondary Outcomes (21)

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).

  2 hours following intervention.

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).

  4 hours following intervention.

• Visual analogue measure of hunger, satiety, fullness, and prospective food consumption (Flint et al., 2000).

  6 hours following intervention.

• EEG Spectral Analysis.

  2 hours following intervention.

• EEG Spectral Analysis.

  4 hours following intervention.

Study Arms (2)

Control - 50g Walnut

EXPERIMENTAL

Control condition followed by experimental condition.

Other: Control; Other: 50 g Walnut

50 g Walnut - Control

EXPERIMENTAL

Experimental condition followed by control condition.

Other: Control; Other: 50 g Walnut

Interventions

Control OTHER

100 grams breakfast cereal

50 g Walnut - Control; Control - 50g Walnut

50 g Walnut OTHER

50 grams walnuts mixed with 50 gram breakfast cereal.

50 g Walnut - Control; Control - 50g Walnut

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Normal or corrected hearing and vision

You may not qualify if:

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

Sponsors & Collaborators

• University of Reading: lead
• California Walnut Commission: collaborator
• Tufts University: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (17)

• 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.

  PMID: 26690214 BACKGROUND

• Carey 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.

  PMID: 23321679 BACKGROUND

• Fisher 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.

  PMID: 25153536 BACKGROUND

• Gomez-Pinilla F. Brain foods: the effects of nutrients on brain function. Nat Rev Neurosci. 2008 Jul;9(7):568-78. doi: 10.1038/nrn2421.

  PMID: 18568016 BACKGROUND

• Haider 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.

  PMID: 22048906 BACKGROUND

• Martinez-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.

  PMID: 23670794 BACKGROUND

• Miller 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.

  PMID: 28011241 BACKGROUND

• Nooyens 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.

  PMID: 21477405 BACKGROUND

• O'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.

  PMID: 24886736 BACKGROUND

• Perez-Cano FJ, Castell M. Flavonoids, Inflammation and Immune System. Nutrients. 2016 Oct 21;8(10):659. doi: 10.3390/nu8100659.

  PMID: 27775647 BACKGROUND

• Poulose 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.

  PMID: 22917841 BACKGROUND

• Pribis 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.

  PMID: 21923981 BACKGROUND

• Ros 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.

  PMID: 23897849 BACKGROUND

• Sanchez-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.

  PMID: 22005283 BACKGROUND

• Valls-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.

  PMID: 25961184 BACKGROUND

• Willis LM, Shukitt-Hale B, Cheng V, Joseph JA. Dose-dependent effects of walnuts on motor and cognitive function in aged rats. Br J Nutr. 2009 Apr;101(8):1140-4. doi: 10.1017/S0007114508059369.

  PMID: 18778529 BACKGROUND

• Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083.

  PMID: 10702749 BACKGROUND

Study Officials

• Claire M Williams, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Neuroscience

Model Details: Participants will be assigned to both the walnut and control conditions in a randomised order.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 30, 2019
• Study Start: November 8, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

GB (1)