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

March 11, 2019 updated by: Northumbria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo consumed daily for a period of 28 days
Experimental: Active treatment
Nut components
Other: Nut components
nut components consumed daily for a period of 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Logical reasoning
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - executive function
At 28 days post dose, adjusted for baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location learning
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - spatial memory
At 28 days post dose, adjusted for baseline
Choice reaction time
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - attention
At 28 days post dose, adjusted for baseline
Rapid Visual Information Processing
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - working memory
At 28 days post dose, adjusted for baseline
Numeric working memory
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - working memory
At 28 days post dose, adjusted for baseline
Stroop
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - executive function
At 28 days post dose, adjusted for baseline
Peg and Ball
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - executive function
At 28 days post dose, adjusted for baseline
Word recall
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - episodic memory
At 28 days post dose, adjusted for baseline
Word recognition
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - episodic memory
At 28 days post dose, adjusted for baseline
Picture recognition
Time Frame: At 28 days post dose, adjusted for baseline
Cognition - episodic memory
At 28 days post dose, adjusted for baseline
Bond-Lader
Time Frame: At 28 days post dose, adjusted for baseline
Mood
At 28 days post dose, adjusted for baseline
Profile of Mood States (POMS)
Time Frame: At 28 days post dose, adjusted for baseline
Mood
At 28 days post dose, adjusted for baseline
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
At 28 days post dose, adjusted for baseline
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.
At 28 days post dose, adjusted for baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

International Nut and Dried Fruit Council

Investigators

  • Principal Investigator: Crystal Haskell-Ramsay, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2017

Primary Completion (Actual)

October 19, 2018

Study Completion (Actual)

October 19, 2018

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 51BQ1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Function

Clinical Trials on Nut components

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe