Effects of Time of Day and Nut Intake on Cognitive Performance

Effects of Time of Day and Nut Intake on Cognitive Performance: a Crossover Trial in Healthy Adults

This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Performance
• Intervention / Treatment: Other: Nut-free meal; Other: Nuts

Detailed Description

In this trial, eligible participants will receive isocaloric meals with or without nuts at lunchtime and dinner time. Cognitive performance will be performed before and 90 min after the meals.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxine Bonham, PhD; Phone Number: +61418234292; Email: maxine.bonham@monash.edu
• Study Contact Backup: Name: Barbara R Cardoso, PhD; Phone Number: +61499840472; Email: barbara.cardoso@monash.edu

Study Locations

• Australia
  • Victoria
    • Notting Hill, Victoria, Australia, 3168
      • Recruiting
      • Department of Nutrition, Dietetics and Food - Monash University
      • Contact: Barbara R Cardoso, PhD; Phone Number: +61499840472; Email: barbara.cardoso@monash.edu
      • Contact: Maxine Bonham, PhD; Phone Number: +61418 234 292; Email: maxine.bonham@monash.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Non-shift workers
• 18-55 years
• BMI between 18.5 and 27 kg/m2,
• Non-smokers
• Without chronic illnesses

Exclusion Criteria:

• Allergy to nuts
• BMI<18.5 or >27 kg/m2
• Presence of dementia or psychiatric disease (depression, Parkinson's disease, schizophrenia)
• Presence of diabetes, serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery, cardiovascular disease
• Presence of any sleep disorders
• Taking anti-diabetic or lipid-lowering medication
• Do not speak English
• Pregnant or planning on becoming pregnant
• Breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Lunch nut-free meal; Participants will receive an isocaloric meal without nuts at lunchtime.	Other: Nut-free meal; Isocaloric meal without nuts
Experimental: Lunch nut meal; Participants will receive an isocaloric meal with nuts at lunchtime.	Other: Nuts; Isocaloric meal with nuts
Placebo Comparator: Dinner nut-free meal; Participants will receive an isocaloric meal without nuts at dinner.	Other: Nut-free meal; Isocaloric meal without nuts
Experimental: Dinner nut meal; Participants will receive an isocaloric meal with nuts at dinner.	Other: Nuts; Isocaloric meal with nuts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N-back task - accuracy	Difference in the total accuracy	before meal x 90 min post-meal
N-back task - matched responses	Difference in the % matched responses	before meal x 90 min post-meal
N-back task - false alarm	Difference in the % false alarm	before meal x 90 min post-meal
N-back task - reaction time	Difference in the reaction time for correct matched responses	before meal x 90 min post-meal
Stroop test - congruent	Difference in the reaction time for congruent	before meal x 90 min post-meal
Stroop test - incongruent	Difference in the reaction time for incongruent	before meal x 90 min post-meal
Stroop test - interference	Difference in stroop interference (incongruent - congruent response time)	before meal x 90 min post-meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multitasking - pure blocks	Difference in the reaction time for pure blocks	before meal x 90 min post-meal
Multitasking - mixed blocks	Difference in the reaction time for mixed blocks	before meal x 90 min post-meal
Multitasking - mixing cost	Difference in mixing cost (mixed - pure reaction time)	before meal x 90 min post-meal
Satiety - hunger	Difference in postprandial hunger	Hunger will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - fullness	Difference in postprandial fullness	Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - satisfaction	Difference in postprandial satisfaction	Satisfaction will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety - eating capacity	Difference in postprandial eating capacity,	Eating capacity will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Satiety index	Difference in postprandial satiety index, calculated using the mean of the four satiety questions, where "hunger" and "eating capacity" will be scored in an inverse way than "fullness" and "satisfaction".	Satiety index will be assessed before the meal and 4 times after the meal (15, 30, 60 and 90 mins).

Collaborators and Investigators

• Sponsor: Monash University
• Investigators: Principal Investigator: Barbara R Cardoso, PhD, Department of Nutrition, Dietetics and Food - Monash University; Principal Investigator: Maxine Bonham, PhD, Department of Nutrition, Dietetics and Food - Monash University; Principal Investigator: Helen Macpherson, PhD, Deakin University

Study record dates

Study Major Dates

• Study Start (Estimated): April 8, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 42038

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