Effects of Time of Day and Nut Intake on Cognitive Performance

Cognitive Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343142
• Other study ID #: 42038
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Monash University
• Contact: Barbara R Cardoso, PhD
• Phone: +61499840472
• Email: barbara.cardoso[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance

Intervention

Other:
• Nuts
Isocaloric meal with nuts
• Nut-free meal
Isocaloric meal without nuts

Locations

Country	Name	City	State
Australia	Department of Nutrition, Dietetics and Food - Monash University	Notting Hill	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-back task - accuracy	Difference in the total accuracy	before meal x 90 min post-meal
Primary	N-back task - matched responses	Difference in the % matched responses	before meal x 90 min post-meal
Primary	N-back task - false alarm	Difference in the % false alarm	before meal x 90 min post-meal
Primary	N-back task - reaction time	Difference in the reaction time for correct matched responses	before meal x 90 min post-meal
Primary	Stroop test - congruent	Difference in the reaction time for congruent	before meal x 90 min post-meal
Primary	Stroop test - incongruent	Difference in the reaction time for incongruent	before meal x 90 min post-meal
Primary	Stroop test - interference	Difference in stroop interference (incongruent - congruent response time)	before meal x 90 min post-meal
Secondary	Multitasking - pure blocks	Difference in the reaction time for pure blocks	before meal x 90 min post-meal
Secondary	Multitasking - mixed blocks	Difference in the reaction time for mixed blocks	before meal x 90 min post-meal
Secondary	Multitasking - mixing cost	Difference in mixing cost (mixed - pure reaction time)	before meal x 90 min post-meal
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).