Clinical trial NCT03979027: Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children
Official title: Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children: A School-based, Randomised, Controlled, Parallel Groups Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Cognition
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Kellogg Company
First posted: 2019-06-07
Enrollment: 234
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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. The study sample consisted of males and females aged 11-13 years who were recruited to take part in the study from a UK secondary school. There were two conditions in this parallel groups study: Breakfast and No breakfast (fasting). The breakfast intervention consisted of ad libitum intake of ready-to-eat-cereal with milk. Cognitive function was assessed at baseline and +70 and +215 minutes post-intervention. The Cambridge Neuro-psychological Test Automated Battery (CANTAB; Cambridge Cognition Ltd) was used to assess cognitive function. The battery included: Simple Reaction Time (SRT), 5-Choice Reaction Time (5-CRT), Rapid Visual Information Processing (RVIP), and Paired Associates Learning (PAL), which measured reaction time, visual-sustained attention, and visual-spatial memory respectively. Concomitant ratings of subjective mood, alertness, satiety, and motivation were taken throughout the morning using eight unipolar Visual Analogue Scales

Eligibility criteria: The inclusion criteria were as follows: aged 11-13 years, willingness to consume RTEC with semi-skimmed cow's milk during the study, ability to follow verbal and written instructions in English, and normal vision with appropriate corrective lenses if required. The exclusion criteria were as follows: inability to understand the objective of the cognitive tests or carry out the tests, behavioural difficulties or attention disorders, administration of any psychotropic medication in the month prior to testing or during testing, food allergies or intolerances which prevent consumption of RTEC and milk (e.g. coeliac, lactose intolerance), acute illness or feeling unwell within the week prior to testing or during testing, and hearing impairment that precluded the normal use of headphones.

Primary outcomes:
measure: Change from baseline Paired Associates Learning (PAL) performance
timeFrame: baseline, 70 minutes post-intervention.
Secondary outcomes:
measure: Simple Reaction Time task performance
timeFrame: baseline, 70 minutes and 215 minutes post-intervention
measure: 5-Choice Reaction Time task performance
timeFrame: baseline, 70 minutes and 215 minutes post-intervention
measure: Rapid Visual Information Processing task (RVIP) performance
timeFrame: baseline, 70 minutes and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of hunger
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of cheerfulness
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of energy
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of motivation to try hard
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of ease of distraction
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of ease of focusing
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of feeling of awake
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of bad temperedness
timeFrame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of cognitive test battery difficulty
timeFrame: baseline, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of concentration during the cognitive test battery
timeFrame: baseline, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of performance on the cognitive test battery
timeFrame: baseline, 70 minutes, and 215 minutes post-intervention
measure: Subjective unipolar visual analogue scale ratings of frustration during the cognitive test battery
timeFrame: baseline, 70 minutes, and 215 minutes post-intervention
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Human Appetite Research Unit, University of Leeds
state: West Yorkshire
Study officials:
References:
citation: 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.