The Effects of Breakfast on Neuropsychological Functioning

NCT01943604 | Completed

• 1 other identifier: H-28698
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine healthy children who skip breakfast and the effects of fasting on their neuropsychological functioning and the potential benefits that a Balanced Breakfast may have on their learning abilities. It is expected that this study will provide new knowledge on how prolonged periods of 8 or more hours without food affect neurocognitive processes and thus learning how specific meals following this period of fasting, which most children experience, change those processes, potentially for the better. The hypotheses for this study are:

1. 1.Children who consume breakfast will demonstrate significantly higher levels of attention, greater concentration, and diminished impulsivity compared to children who do not consume breakfast.
2. 2.Children who consume breakfast will demonstrate a significantly quicker reaction time and increased accuracy in correctly identifying target stimuli from an array compared to children who do not consume breakfast.
3. 3.Children who consume breakfast will demonstrate increased freedom from distractibility and enhanced short-term memory compared to children who do not consume breakfast.
4. 4.Children who consume breakfast will demonstrate increased cognitive processing speed compared to children who do not consume breakfast.
5. 5.Children who consume breakfast will have improved verbal learning compared to children who do not consume breakfast.
6. 6.Children who consume breakfast will have improved visual memory compared to children who do not consume breakfast.

Conditions

Neuropsychology

Keywords

Neuropsychology; Breakfast eating patters; Glucose; Child Psychology

Outcome Measures

Primary Outcomes (6)

• Visual Search Paradigm change across three timepoints

  The Padova Visual Search Paradigm will be used to assess sustained attention. This measure requires the participant to make a decision about the presence of a specified target object in an array of simultaneously presented objects. Stimulus generation and response recording will be conducted by a software package E-Prime 2.0 and running on a Pentium PC connected to a 13-inch screen. The protocol developed by Padova for children will be used in this study.

  Administered three times across three months

• CPT-II change across three timepoints

  A normed computerized test designed to assess attention, vigilance, and impulsivity. Reaction times and accuracy are also calculated. This measure takes 14 minutes to complete and can be administered to individuals ranging in age from 6 years old to 55+ years. This task involves the subjects sitting in front of a computer screen while letters of the alphabet are flashed briefly, at various inter-stimulus intervals. The subject is instructed to press the spacebar on the keyboard whenever a letter is seen on the screen, except the letter "X". The CPT-II will also be used to examine the correlation with the experimental visual search measure, and possibly offer external validity.

  Administered three times across three months

• WISC-IV subtests (Working Memory/Attention) change across three timepoints

  The Wechsler Intelligence Scale for Children-IV (WISC-IV) is an individually administered, comprehensive clinical instrument designed to assess intellectual functioning in children ages 6 years, 0 months to 16 years, 11 months. 1. Digit Span - this subtest is composed of 2 parts, Digit Span Forward and Digit Span Backwards. This subtest is designed as a measure of auditory short-term memory, sequencing skills, attention, and concentration (Sattler, 2001). Each of the 2 parts of this subtest involves different discrete areas of cognition. 2. Letter-Number Sequencing - this subtest is one of the core Working Memory Composite tests. The subject is provided a sequence of numbers and letters, and is asked to recall the numbers in descending order and the letters in alphabetical order.

  Administered three times across three months

• WRAML2 subtests change across three timepoints

  The Wide Range Assessment of Memory and Learning- Second Edition (WRAML 2) is a battery of subtests designed to examine the memory abilities in individuals ages 5 to over 85. The subtests to be administered in this study are the following : 1. The Verbal Learning subtest - The task evaluates a person's ability to actively learn unrelated verbal material. For subjects ages 8 years and younger, 13 words are used. For subjects 9 years and older, 16 words make up this list-learning tasks. A subtest Scale Score is obtained based on the total number of words remembered correctly on the 4 learning trials. 2. The Picture Memory subtest - is a test designed to assess visual memory.

  Administered three times across three months

• TOMAL subtest change across three timepoints

  The Test of Memory and Learning (TOMAL) is a comprehensive memory battery standardized for use with children and young adults. a) Visual Selective Reminding (VSR) - is a nonverbal analog to the Word Selective Reminding (WSR) subtest of the TOMAL. The subjects are required to point to specified dots on a card, following a demonstration by the examiner, and are reminded only of the items recalled incorrectly. Trials continue until mastery is achieved or until 8 trials have been attempted. It is designed to assess learning and immediate recall functions of visual (nonverbal) memory.

  Administered three times across three months

• WISC-IV subtests (Processing Speed) change across three timepoints

  For each of the subtests, the distribution of each age group's total raw scores is converted to scaled scores with a mean of 10 and a standard deviation (SD) of 3. 1. Coding - In addition to cognitive processing speed, the subtest measures/involves short-term memory, learning ability, visual perception, visual-motor coordination, visual scanning ability, cognitive flexibility, attention, and motivation (Sattler, 2001). 2. Symbol Search - In addition to processing speed, the subtest also involves short-term visual memory, visual-motor coordination, cognitive flexibility, visual discrimination, and concentration (Sattler, 2001).

  Administered three times across three months

Secondary Outcomes (8)

• Blood Ketones

  Blood draws occur before and after each breakfast treatment and neuropsychological testing for a total of 6 blood draws across 3 months

• Demographic Questionnaire

  Administered one time across three months

• Breakfast Consumption Patterns

  Administered one time across three months

• Food Insecurity Scale

  Administered one time across three months

• Children's Sleep Habits Questionnaire (CSHQ)

  Administered one time across three months

Study Arms (1)

Experimental

EXPERIMENTAL

Nutella Breakfast Waffle Breakfast

Other: Nutella Breakfast; Other: Waffle Breakfast

Interventions

Nutella Breakfast OTHER

Breakfast composed of bread and Nutella, milk and apple slices

Experimental

Waffle Breakfast OTHER

Breakfast composed of waffles and syrup, milk, and apple slices

Experimental

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 8-10 years of age will be recruited from Houston, Texas
• Low socio-economic (SES) children and middle income children (defined as those who receive "free" and "reduced fee" lunches from the respective schools within the district)

You may not qualify if:

• Children with weights below the 10th percentile and above the 90th percentile will be excluded
• Children will be examined by a trained nurse to rule out color blindness
• Children with a history of neurological, neurodevelopmental, developmental learning disabilities, sensory impairments, mood disorders, attention deficit hyperactivity disorder, acute or chronic medical conditions, reported lactose intolerance, veganism, asthma, tree nut and/or peanut allergy, anemia, pubescent, on prescription medications or a Tanner stage greater than 2 will be excluded from the study
• Subjects who are unwilling to consume Nutella or have dietary restrictions that would prevent them from consuming the prepared meals will not be included

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Ferrero Italy, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Iovino I, Stuff J, Liu Y, Brewton C, Dovi A, Kleinman R, Nicklas T. Breakfast consumption has no effect on neuropsychological functioning in children: a repeated-measures clinical trial. Am J Clin Nutr. 2016 Sep;104(3):715-21. doi: 10.3945/ajcn.116.132043. Epub 2016 Jul 27.

  PMID: 27465375 DERIVED

Study Officials

• Theresa Nicklas, DrPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Isabella Iovino, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Janice Stuff, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: September 17, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

US (1)