Clinical trial NCT06343142: Effects of Time of Day and Nut Intake on Cognitive Performance
Official title: Effects of Time of Day and Nut Intake on Cognitive Performance: a Crossover Trial in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 x 2-factor crossover design study
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: N-back task - accuracy
timeFrame: before meal x 90 min post-meal
measure: N-back task - matched responses
timeFrame: before meal x 90 min post-meal
measure: N-back task - false alarm
timeFrame: before meal x 90 min post-meal
measure: N-back task - reaction time
timeFrame: before meal x 90 min post-meal
measure: Stroop test - congruent
timeFrame: before meal x 90 min post-meal
measure: Stroop test - incongruent
timeFrame: before meal x 90 min post-meal
measure: Stroop test - interference
timeFrame: before meal x 90 min post-meal
Secondary outcomes:
measure: Multitasking - pure blocks
timeFrame: before meal x 90 min post-meal
measure: Multitasking - mixed blocks
timeFrame: before meal x 90 min post-meal
measure: Multitasking - mixing cost
timeFrame: before meal x 90 min post-meal
measure: Satiety - hunger
timeFrame: Hunger will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
measure: Satiety - fullness
timeFrame: Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
measure: Satiety - satisfaction
timeFrame: Satisfaction will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
measure: Satiety - eating capacity
timeFrame: 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).
measure: Satiety index
timeFrame: Satiety index will be assessed before the meal and 4 times after the meal (15, 30, 60 and 90 mins).
Other outcomes:
Locations:
city: Notting Hill
country: Australia
facility: Department of Nutrition, Dietetics and Food - Monash University
state: Victoria
Study officials:
affiliation: Department of Nutrition, Dietetics and Food - Monash University
name: Barbara R Cardoso, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Dietetics and Food - Monash University
name: Maxine Bonham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deakin University
name: Helen Macpherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: