NCT03979027

Brief Summary

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2011

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

June 3, 2019

Last Update Submit

June 6, 2019

Conditions

Healthy

Keywords

Cognition

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Paired Associates Learning (PAL) performance

    Paired Associates Learning (PAL) task was administered on individual touchscreen portable computers.

    baseline, 70 minutes post-intervention.

Secondary Outcomes (15)

  • Simple Reaction Time task performance

    baseline, 70 minutes and 215 minutes post-intervention

  • 5-Choice Reaction Time task performance

    baseline, 70 minutes and 215 minutes post-intervention

  • Rapid Visual Information Processing task (RVIP) performance

    baseline, 70 minutes and 215 minutes post-intervention

  • Subjective unipolar visual analogue scale ratings of hunger

    baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

  • Subjective unipolar visual analogue scale ratings of cheerfulness

    baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

  • +10 more secondary outcomes

Study Arms (2)

No Breakfast

NO INTERVENTION

Fasting. Ad libitum water intake permitted.

Breakfast

EXPERIMENTAL

Ad libitum intake of ready-to-eat-cereal with milk. Participants were given a choice of four commercially available RTECs with 1.8% fat cow's milk. Ad libitum water intake was also permitted. The four ready-to-eat-cereals were corn flakes, toasted rice, shredded whole wheat pieces with a sugar topping, and wheat, corn and oat shapes.

Dietary Supplement: Breakfast: ready-to-eat-cereal and milk

Interventions

Breakfast: ready-to-eat-cereal and milkDIETARY_SUPPLEMENT
Breakfast

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

Location

Related Publications (1)

  • Adolphus K, Hoyland A, Walton J, Quadt F, Lawton CL, Dye L. Ready-to-eat cereal and milk for breakfast compared with no breakfast has a positive acute effect on cognitive function and subjective state in 11-13-year-olds: a school-based, randomised, controlled, parallel groups trial. Eur J Nutr. 2021 Sep;60(6):3325-3342. doi: 10.1007/s00394-021-02506-2. Epub 2021 Feb 20.

    PMID: 33609174DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Louise Dye

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 7, 2019

Study Start

January 4, 2011

Primary Completion

April 28, 2011

Study Completion

April 28, 2011

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)