Effects of Time of Day and Nut Intake on Cognitive Performance

NCT06343142 | Completed DMC

• 1 other identifier: Nuts for thought
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Performance

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (8)

• Multitasking - pure blocks

  before meal x 90 min post-meal

• Multitasking - mixed blocks

  before meal x 90 min post-meal

• Multitasking - mixing cost

  before meal x 90 min post-meal

• Satiety - 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

  Fullness will be assessed with a visual analog scale before the meal and 4 times after the meal (15, 30, 60 and 90 mins).

Study Arms (4)

Lunch nut-free meal

PLACEBO COMPARATOR

Participants will receive an isocaloric meal without nuts at lunchtime.

Other: Nut-free meal

Lunch nut meal

EXPERIMENTAL

Participants will receive an isocaloric meal with nuts at lunchtime.

Other: Nuts

Dinner nut-free meal

PLACEBO COMPARATOR

Participants will receive an isocaloric meal without nuts at dinner.

Other: Nut-free meal

Dinner nut meal

EXPERIMENTAL

Participants will receive an isocaloric meal with nuts at dinner.

Other: Nuts

Interventions

Nuts OTHER

Isocaloric meal with nuts

Dinner nut meal; Lunch nut meal

Nut-free meal OTHER

Isocaloric meal without nuts

Dinner nut-free meal; Lunch nut-free meal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Department of Nutrition, Dietetics and Food - Monash University

Notting Hill, Victoria, 3168, Australia

Location

MeSH Terms

Interventions

Nuts

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: 2 x 2-factor crossover design study

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start: April 8, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)