NCT06900452

Brief Summary

This study aims to investigate the effect of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on cognitive function throughout the course of the day in healthy ageing adults aged 65-80.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

March 21, 2025

Last Update Submit

May 2, 2025

Conditions

Keywords

CognitionPistachiosVascularNeuralInflammationMood

Outcome Measures

Primary Outcomes (4)

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    Baseline

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    2 hours

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    4 hours

  • Delayed recall (Rey Auditory Verbal Learning Task)

    The RAVLT is a verbal learning task that presents participants with 15 words (list A) 5 times, giving participants one minute after each presentation to recall as many words as they can from the list. After 5 presentations, a new list (list B) is presented and recalled, and finally participants are asked (without hearing list A again) to recall as many words as they can from list A. After a 30 minute period, participants are asked to think back to the task and recall as many words as possible from list A only, providing a measure of delayed recall.

    6 hours

Secondary Outcomes (36)

  • Rate of learning (Rey Auditory Verbal Learning Task)

    Baseline

  • Rate of learning (Rey Auditory Verbal Learning Task)

    2 hours

  • Rate of learning (Rey Auditory Verbal Learning Task)

    4 hours

  • Rate of learning (Rey Auditory Verbal Learning Task)

    6 hours

  • Word recognition (Rey Auditory Verbal Learning Task)

    Baseline

  • +31 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Macronutrient-matched placebo breakfast meal

Dietary Supplement: Placebo

0.5 servings of pistachio

EXPERIMENTAL

0.5 servings of pistachio (15g) administered in breakfast meal

Dietary Supplement: 0.5 serving of pistachios

1 serving of pistachio

EXPERIMENTAL

1 serving of pistachio (30g) administered in breakfast meal

Dietary Supplement: 1 serving of pistachios

2 servings of pistachio

EXPERIMENTAL

2 servings of pistachio (60g) administered in breakfast meal

Dietary Supplement: 2 servings of pistachios

Interventions

0.5 serving of pistachiosDIETARY_SUPPLEMENT

The equivalent of 0.5 servings (15g) of shelled, roasted pistachio nuts, crushed and mixed into a muesli-based breakfast meal for consumption. Ingredients: 15g pistachio, 35g muesli base, 150g full fat natural yoghurt, 15g unsalted butter (melted), 10g unflavoured whey powder

0.5 servings of pistachio
1 serving of pistachiosDIETARY_SUPPLEMENT

The equivalent of 1 serving (30g) of shelled, roasted pistachio nuts, crushed and mixed into a muesli-based breakfast meal for consumption. Ingredients: 30g pistachio, 35g muesli base, 150g full fat natural yoghurt, 10g unsalted butter (melted), 5g unflavoured whey powder

1 serving of pistachio
2 servings of pistachiosDIETARY_SUPPLEMENT

The equivalent of 2 servings (60g) of shelled, roasted pistachio nuts, crushed and mixed into a muesli-based breakfast meal for consumption. Ingredients: 60g pistachios, 25g muesli base, 150g low fat natural yoghurt

2 servings of pistachio
PlaceboDIETARY_SUPPLEMENT

Macronutrient-matched placebo breakfast meal. Ingredients: 40g muesli base, 150g full fat natural yoghurt, 25g unsalted butter (melted), 15g unflavoured whey powder

Placebo

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old
  • Fruit \& veg intake less than or equal to 4 servings per day
  • Not regularly consuming more than 3 servings of fish per week
  • Adequate English language and visual \& auditory acuity to perform the cognitive tasks
  • Normal BMI for age
  • Normal MMSE performance between 26-30

You may not qualify if:

  • Being diagnosed with psychological or psychiatric disorders
  • ADHD or dyslexia
  • Any food allergy or intolerance
  • Use of medications and dietary supplements that may impact study results
  • Antibiotic use within the last 3 months
  • Adherence to vegan or vegetarian diets, or other specific diets that may impact study outcomes
  • Being diagnosed with cardiometabolic disease (including type II diabetes and cardiovascular disease), or suffer from untreated hypertension or thrombosis related disorders
  • Taking blood thinners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition, Cognition & Health Lab, School of Psychology and Clinical Language Sciences, University of Reading

Reading, Berkshire, RG6 6ES, United Kingdom

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claire Williams, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

March 6, 2025

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

May 7, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

All relevant study outcomes described in the Ethics Review Application Form, including demographics, anthropometrics, cognitive performance, blood tests FMD and EEG data, will be preserved and made available via a data repository, such as the University of Reading data repository, in anonymised form, so that they can be consulted and re-used by others.

Locations