The Effect of Pistachio-Rich Breakfast Meals on Cognitive Function in Healthy Older Adults

NCT ID: NCT06900452

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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This crossover RCT investigates the acute postprandial effect (over a 6-hour period) of a breakfast meal containing varying serving sizes (doses) of pistachio nuts on the cognitive behaviour in healthy adults aged 65-80 years old. The study will also assess markers of inflammation and brain health by taking blood samples, and explore brain function (EEG) and blood flow (FMD) to understand how pistachio nuts may positively influence cognitive health. The study will involve a screening visit and four testing visits, with a week interval between each. On the evening prior to each test visit, participants are asked not to consume any food or drinks expect water, including tea/coffee and alcohol, after 8.30pm, and on the morning of test visits to only consume one slice of buttered white toast and a glass of water prior to attending the visit. During the four testing visits, cognitive and mood battery tests will be taken at baseline and then at 2-, 4- and 6-hour intervals following the consumption of the intervention meal. Blood draws are taken at the end of the day. For the subset of participants taking part in FMD, this will be measured at baseline, 2, 4 and 6 hours prior to cognitive testing. For those taking part in EEG, this data will be collected at 6 hours.

Conditions

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Macronutrient-matched placebo breakfast meal

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

0.5 servings of pistachio

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

Group Type EXPERIMENTAL

0.5 serving of pistachios

Intervention Type DIETARY_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

1 serving of pistachio

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

Group Type EXPERIMENTAL

1 serving of pistachios

Intervention Type DIETARY_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

2 servings of pistachio

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

Group Type EXPERIMENTAL

2 servings of pistachios

Intervention Type DIETARY_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

Interventions

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0.5 serving of pistachios

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

Intervention Type DIETARY_SUPPLEMENT

1 serving of pistachios

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

Intervention Type DIETARY_SUPPLEMENT

2 servings of pistachios

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 65 - 80 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

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Pistachio Growers

OTHER

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Prof Claire Williams

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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

Reading, Berkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Claire Williams, PhD

Role: CONTACT

0118 378 7540

Lynne Bell, PhD

Role: CONTACT

0118 378 8313

Other Identifiers

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2024-236-CW

Identifier Type: -

Identifier Source: org_study_id

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