Clinical trial NCT02122224: Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Satiety
Dietary Modification
Memory Deficits
Obesity
Keywords: satiety
satiation
diet quality
memory
obesity
protein
fiber
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: One important factor determining school performance is the consumption of breakfast. While research has shown that older children perform better in school after consuming breakfast, there are little data for preschool-age children. Consuming breakfasts with different macro- and micronutrient contents may have different effects on performance, which may be associated with variations in satiation and satiety during and after the different breakfasts. In addition, children who consume breakfast have better diet quality than children who skip breakfast.

The investigators will conduct a community based, randomized, crossover trial in 4-5 year old children over 7 weeks to examine the short-term effect of feeding preschoolers three different intervention breakfast types: high protein, high-fiber, or high protein and high fiber compared to a usual breakfast served at the preschool. The investigators expect that the children consuming any of the three experimental breakfasts will consume less overall calories and have better diet quality and memory performance compared to children who have the usual breakfast. The investigators hypothesis is that preschoolers will experience the highest level of satiety as well as highest level of overall diet quality when they consume the combined high-protein and high-fiber based breakfast foods.

This study will be conducted at Bauer Family Resources in Lafayette as these are the sites of Head Start programs, which are preschools for children from low-income families. Children from families of low income are more likely to have poor diet quality and poor school performance compared to children from families with higher incomes. Therefore, this population is most in need of this type of intervention.


Eligibility criteria: Inclusion Criteria:

* 4-5 year old children attending Head Start centers in Lafayette, IN. Males and females of all racial and ethnic background are included.

Exclusion Criteria:

* No digestive disorders, food allergies, or kidney disease. Children cannot be taking medication that would affect appetite.

Primary outcomes:
measure: Change in reports of hunger/fullness_Baseline
timeFrame: Baseline
measure: Diet Quality_Baseline
timeFrame: Baseline
measure: Changes in memory_Baseline
timeFrame: baseline
measure: Change in reports of hunger/fullness_Week 3
timeFrame: Week 3
measure: Change in reports of hunger/fullness_Week 5
timeFrame: Week 5
measure: Change in reports of hunger/fullness_Week 7
timeFrame: Week 7
measure: Diet Quality_Week 1
timeFrame: Week 1
measure: Diet Quality_Week 3
timeFrame: Week 3
measure: Diet Quality_Week 5
timeFrame: Week 5
measure: Diet Quality_Week 7
timeFrame: Week 7
measure: Changes in memory_Week 1
timeFrame: Week 1
measure: Changes in memory_Week 3
timeFrame: Week 3
measure: Changes in memory_Week 5
timeFrame: Week 5
measure: Changes in memory_Week 7
timeFrame: Week 7
Secondary outcomes:
measure: Changes in weight/body fat_Baseline
timeFrame: Baseline
measure: Assessing children's usual breakfast habits
timeFrame: Baseline
measure: Changes in weight/body fat_Week 1
timeFrame: Week 1
measure: Changes in weight/body fat_Week 3
timeFrame: Week 3
measure: Changes in weight/body fat_Week 5
timeFrame: Week 5
measure: Changes in weight/body fat_Week 7
timeFrame: Week 7
measure: Sleep habits_Baseline
timeFrame: Baseline
measure: Sleep habits_Week 1
timeFrame: Week 1
measure: Sleep habits_Week 3
timeFrame: Week 3
measure: Sleep habits_Week 5
timeFrame: Week 5
measure: Sleep habits_Week 7
timeFrame: Week 7
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Bauer Family Resources (Head Start)
state: Indiana
Study officials:
affiliation: Purdue University
name: Sibylle Kranz, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. High-Protein and High-Dietary Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast. J Nutr. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.