Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-01 @ 7:59 PM
Study NCT ID:
NCT01943604
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Breakfast on Neuropsychological Functioning
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
The Effects of Breakfast on Neuropsychological Functioning in Children Ages 8-10 From Low to Middle Income Families
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: