Clinical trial NCT01943604: The Effects of Breakfast on Neuropsychological Functioning
Official title: The Effects of Breakfast on Neuropsychological Functioning in Children Ages 8-10 From Low to Middle Income Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropsychology
Keywords: Neuropsychology
Breakfast eating patters
Glucose
Child Psychology
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Ferrero Italy, Inc.
First posted: 2013-09-17
Enrollment: 195
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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. 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. 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. Children who consume breakfast will demonstrate increased freedom from distractibility and enhanced short-term memory compared to children who do not consume breakfast.
4. Children who consume breakfast will demonstrate increased cognitive processing speed compared to children who do not consume breakfast.
5. Children who consume breakfast will have improved verbal learning compared to children who do not consume breakfast.
6. Children who consume breakfast will have improved visual memory compared to children who do not consume breakfast.

Detailed description: Hunger can be considered a chronic health condition. Among children, the lack of available food to meet usual physical needs on a regular basis leads to poor cognitive and behavioral performance and is associated with adverse physical and mental health outcomes. All of these findings are well documented among poor children living in families with sufficient food and are exacerbated even more among those in families living under conditions of food insufficiency. There has been a significant effort over the past 2 decades to document the effects of mechanisms of how hunger affects learning, cognitive performance, and behavior and how a meal, such as breakfast can mitigate those effects.

The longest period during a 24-hour day when children go without food is the period from the beginning of sleep at night to the first meal of the following day. Therefore, the morning seems an ideal time to examine those biological factors that result from hunger or fasting and how they affect basic processes that underpin learning and behavior. Underprivileged but otherwise healthy children seem most affected by hunger. Thus, studies are needed to compare children from families of different economic income strata to understand better how a breakfast meal might affect those learning and behavioral processes, and whether the breakfast meal truly has a positive effect on basic learning and behavior.

The goal of this study is to evaluate the effects on short-term neuropsychological functioning of: a) consumption of breakfast versus no breakfast (2 different breakfast meals will be employed); and b) consumption of breakfast by groups of children from low income families vs children from families with average/middle incomes, who are 8-10 years of age. The primary outcome will be neuropsychological functioning in specific areas of cognition, as measured by standardized tests. A secondary outcome will be glucose homeostasis, measured by blood ketones and blood glucose and insulin.

A total of 154 children will be recruited with an anticipated 20% drop out rate. The final sample will consist of 64 children in each socioeconomic group (total n=128) who will stay overnight three separate nights and participate in each breakfast condition. The sample will consist of low and middle income African- and Hispanic-Americans and Caucasian male and female children between the ages of 8-10. The sample size will consist of an equal number of boys and girls and will have an equal representation of children from the socioeconomic conditions (i.e. low and middle income) and ethnicities (African and Hispanic Americans and Caucasians) identified.

The design consists of two independent groups based on SES with a crossover, repeated-measures (within subject and across subject design, under three breakfast conditions. The outcome measures (dependent variables) will include a battery of neuropsychological measures. All participating subjects are admitted to the Children's Nutrition Research Center (CNRC) Metabolic Research unit (MRU) three times for overnight stays with intervals of at least 2 weeks apart across 3 months.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Search Paradigm change across three timepoints
timeFrame: Administered three times across three months
measure: CPT-II change across three timepoints
timeFrame: Administered three times across three months
measure: WISC-IV subtests (Working Memory/Attention) change across three timepoints
timeFrame: Administered three times across three months
measure: WRAML2 subtests change across three timepoints
timeFrame: Administered three times across three months
measure: TOMAL subtest change across three timepoints
timeFrame: Administered three times across three months
measure: WISC-IV subtests (Processing Speed) change across three timepoints
timeFrame: Administered three times across three months
Secondary outcomes:
measure: Blood Ketones
timeFrame: Blood draws occur before and after each breakfast treatment and neuropsychological testing for a total of 6 blood draws across 3 months
measure: Demographic Questionnaire
timeFrame: Administered one time across three months
measure: Breakfast Consumption Patterns
timeFrame: Administered one time across three months
measure: Food Insecurity Scale
timeFrame: Administered one time across three months
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Administered one time across three months
measure: Family Inventory of Life Events and Changes (FILE) Questionnaire
timeFrame: Administered one time across three months
measure: Physical Exam
timeFrame: Administered one time across three months
measure: Blood measurements
timeFrame: Blood draws occur before and after each breakfast treatment and neuropsychological testing for a total of 6 blood draws across 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Theresa Nicklas, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Isabella Iovino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Janice Stuff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.