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OpenTrials
Completed

NCT Number: NCT03500601

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

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.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria University

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

About this study

To date, only two small human intervention trials have evaluated the effects of nuts as a sole intervention on cognition. One study reported a benefit verbal fluency and constructional praxis following daily consumption of 6 g brazil nuts for 6 months in older adults diagnosed with mild cognitive impairment. Eight weeks' consumption of 60 g/d walnuts in healthy young adults aged 18-25 years also resulted in improved inferential verbal reasoning scores compared to placebo.

The development of various 'omics' technologies has enabled researchers to investigate the influence of nutrients or dietary change on metabolic pathways at multiple levels with a view to developing biological markers of dietary intake.

Metabolomic approaches have been used successfully to study nut consumption; for example putative biomarkers of nut consumption have been revealed as metabolites associated with serotonin pathways. Furthermore, certain nut biomarkers identified using metabolomics appear to be negatively associated with health parameters which is suggested to be due to gut microbiota dysbiosis and provides an important link between nut consumption, the gut microflora and metabolic pathways.

This study will assess the effects of four weeks' supplementation with nut components on cognition. Metabolomic and metagenomic approaches will be utilised to analyse urinary metabolites and intestinal microbial communities allowing biomarkers of nut exposure to be highlighted. Metabolic and gut microbiota responses will then be correlated with changes in cognition in order to identify inter-individual differences in response, and further understanding of the mechanisms underpinning cognitive benefits of nut consumption.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Have any known active infections
  • Blood pressure >139/89mmHg
  • Are employed in a job that includes night shift work
  • Have habitually used supplements within the last month (defined as more than 3 consecutive days or 4 days in total)

Treatment and study plan

Nut components

Other

nut components consumed daily for a period of 28 days

Placebo

Other

Placebo consumed daily for a period of 28 days

Primary outcomes

  1. Logical reasoning

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - executive function

Secondary outcomes

  1. Location learning

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - spatial memory

  2. Choice reaction time

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - attention

  3. Rapid Visual Information Processing

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - working memory

  4. Numeric working memory

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - working memory

  5. Stroop

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - executive function

  6. Peg and Ball

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - executive function

  7. Word recall

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - episodic memory

  8. Word recognition

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - episodic memory

  9. Picture recognition

    Time frame: At 28 days post dose, adjusted for baseline

    Cognition - episodic memory

  10. Bond-Lader

    Time frame: At 28 days post dose, adjusted for baseline

    Mood

  11. Profile of Mood States (POMS)

    Time frame: At 28 days post dose, adjusted for baseline

    Mood

  12. Urinary metabolites (fingerprinting and profiling)

    Time frame: At 28 days post dose, adjusted for baseline

    Liquid chromatography/mass spectrometry, combined with data mining using specific software to identify specific metabolites influenced by supplementation

  13. Intestinal microbial communities

    Time frame: At 28 days post dose, adjusted for baseline

    Analysis of total DNA using standardised procedures targeting bacteria using the 16S rRNA gene.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • International Nut and Dried Fruit Council

Registry information

Official study title

Effects of Daily Tree Nut Consumption on Cognitive Function, Metabolomics and Intestinal Microbiota

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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