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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03500601
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
International Nut and Dried Fruit Council
Information provided by (Responsible Party):
Northumbria University

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.


Condition or disease Intervention/treatment Phase
Cognitive Function Urinary Metabolites Intestinal Microbiota Other: Nut components Other: Placebo Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 x 4 week intervention with 4 week washout
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Daily Tree Nut Consumption on Cognitive Function, Metabolomics and Intestinal Microbiota
Actual Study Start Date : November 22, 2017
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Arm Intervention/treatment
Experimental: Active treatment
Nut components
Other: Nut components
nut components consumed daily for a period of 28 days

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo consumed daily for a period of 28 days




Primary Outcome Measures :
  1. Logical reasoning [ Time Frame: At 28 days post dose, adjusted for baseline ]
    Cognition - executive function


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500601


Locations
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United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
International Nut and Dried Fruit Council
Investigators
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Principal Investigator: Crystal Haskell-Ramsay Northumbria University
Publications:
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT03500601    
Other Study ID Numbers: 51BQ1
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Cognition
Metagenomics
Metabolomics