Effects of Consumption of Nut Components on Cognitive Function, Intestinal Microbial Communities and Markers of Health

NCT03500601 | Completed

• 1 other identifier: 51BQ1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Tree nuts (for example brazil nuts, almonds, hazelnuts, walnuts, cashew nuts etc) contain a wide variety of nutrients including fatty acids, polyphenols and micronutrients. The beneficial health effects ascribed to the consumption of tree nuts include improvements to cardiovascular outcomes and regulation of glucose levels and inflammation. Emerging evidence suggests that specific components of nuts may also contribute to brain health and function. The aim of the present study is to assess the effects of four weeks' supplementation of nut components on cognition and subjective measures. Urinary metabolites and intestinal microbial communities will also be assessed allowing biomarkers of nut exposure to be highlighted.

Conditions

Cognitive Function; Urinary Metabolites; Intestinal Microbiota

Keywords

Cognition; Metagenomics; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Logical reasoning

  Cognition - executive function

  At 28 days post dose, adjusted for baseline

Secondary Outcomes (13)

• Location learning

  At 28 days post dose, adjusted for baseline

• Choice reaction time

  At 28 days post dose, adjusted for baseline

• Rapid Visual Information Processing

  At 28 days post dose, adjusted for baseline

• Numeric working memory

  At 28 days post dose, adjusted for baseline

• Stroop

  At 28 days post dose, adjusted for baseline

Study Arms (2)

Active treatment

EXPERIMENTAL

Nut components

Other: Nut components

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Nut components OTHER

nut components consumed daily for a period of 28 days

Active treatment

Placebo OTHER

Placebo consumed daily for a period of 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Willing to abstain throughout the trial from any nutritional supplementation
• Willing to abstain throughout the trial from the intake of any nuts or nut containing products

You may not qualify if:

• Aged under 18 or over 49
• Relevant pre-existing medical condition/illness
• Current use of prescription medications (excluding contraception)
• Learning difficulties and dyslexia
• Visual impairment that cannot be corrected with glasses or contact lenses including colour blindness
• Currently suffer from migraines (\> 1 per month)
• Smoking or use of any nicotine replacement products e.g. vaping, gum, patches
• History of or any current food intolerances/sensitivities, including nut/peanut allergies
• Never consumed nuts, or regularly consume nuts more than twice per week
• Irregular bowel function (less than one bowel movement per day)
• Body mass index (BMI) under 18.5 or over 30
• Pregnancy, seeking to become pregnant, or current lactation
• Inability to complete all of the study assessments
• Current participation in other clinical or nutrition intervention studies
• Not proficient in English equivalent to IELTS band 6 or above

Sponsors & Collaborators

• Northumbria University: lead
• International Nut and Dried Fruit Council: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

Related Publications (5)

• Rita Cardoso B, Apolinario D, da Silva Bandeira V, Busse AL, Magaldi RM, Jacob-Filho W, Cozzolino SM. Effects of Brazil nut consumption on selenium status and cognitive performance in older adults with mild cognitive impairment: a randomized controlled pilot trial. Eur J Nutr. 2016 Feb;55(1):107-16. doi: 10.1007/s00394-014-0829-2. Epub 2015 Jan 8.

  PMID: 25567069 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

• Tulipani S, Llorach R, Jauregui O, Lopez-Uriarte P, Garcia-Aloy M, Bullo M, Salas-Salvado J, Andres-Lacueva C. Metabolomics unveils urinary changes in subjects with metabolic syndrome following 12-week nut consumption. J Proteome Res. 2011 Nov 4;10(11):5047-58. doi: 10.1021/pr200514h. Epub 2011 Sep 29.

  PMID: 21905751 BACKGROUND

• Mora-Cubillos X, Tulipani S, Garcia-Aloy M, Bullo M, Tinahones FJ, Andres-Lacueva C. Plasma metabolomic biomarkers of mixed nuts exposure inversely correlate with severity of metabolic syndrome. Mol Nutr Food Res. 2015 Dec;59(12):2480-90. doi: 10.1002/mnfr.201500549. Epub 2015 Oct 21.

  PMID: 26412215 BACKGROUND

• Haskell-Ramsay CF, Dodd FL, Smith D, Cuthbertson L, Nelson A, Lodge JK, Jackson PA. Mixed Tree Nuts, Cognition, and Gut Microbiota: A 4-Week, Placebo-Controlled, Randomized Crossover Trial in Healthy Nonelderly Adults. J Nutr. 2023 Jan 14;152(12):2778-2788. doi: 10.1093/jn/nxac228.

  PMID: 36202391 DERIVED

Study Officials

• Crystal Haskell-Ramsay

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 4 week intervention with 4 week washout

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 18, 2018
• Study Start: November 22, 2017
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: March 13, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)