The Effects of Breakfast on Neuropsychological Functioning

NCT ID: NCT01943604

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Neuropsychology

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Nutella Breakfast

Waffle Breakfast

Group Type: EXPERIMENTAL

Nutella Breakfast

Intervention Type: OTHER

Breakfast composed of bread and Nutella, milk and apple slices

Waffle Breakfast

Intervention Type: OTHER

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

Interventions

Nutella Breakfast

Breakfast composed of bread and Nutella, milk and apple slices

Intervention Type: OTHER

Waffle Breakfast

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ferrero Italy, Inc.

INDUSTRY

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Theresa A Nicklas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Nicklas, DrPH

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Isabella Iovino, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Janice Stuff, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27465375 (View on PubMed)

Other Identifiers

H-28698

Identifier Type: -

Identifier Source: org_study_id