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Clinical Trials/NCT02122224
NCT02122224
Completed
Not Applicable

Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Purdue University1 site in 1 country40 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lack of Satiety
Sponsor
Purdue University
Enrollment
40
Locations
1
Primary Endpoint
Change in reports of hunger/fullness_Baseline
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
May 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wayne Campbell

Prof. Nutrition Science

Purdue University

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.

Outcomes

Primary Outcomes

Change in reports of hunger/fullness_Baseline

Time Frame: Baseline

Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

Diet Quality_Week 5

Time Frame: Week 5

Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

Changes in memory_Week 5

Time Frame: Week 5

The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Diet Quality_Week 7

Time Frame: Week 7

Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

Changes in memory_Week 1

Time Frame: Week 1

The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Diet Quality_Week 3

Time Frame: Week 3

Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

Changes in memory_Week 3

Time Frame: Week 3

The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Change in reports of hunger/fullness_Week 7

Time Frame: Week 7

Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

Diet Quality_Baseline

Time Frame: Baseline

Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

Change in reports of hunger/fullness_Week 3

Time Frame: Week 3

Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

Diet Quality_Week 1

Time Frame: Week 1

Food and beverage intake will be recorded for 1 day at 5 points during the study to assess differences in diet quality and nutrient intake in response to breakfasts with different nutrient contents.

Changes in memory_Baseline

Time Frame: baseline

The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Change in reports of hunger/fullness_Week 5

Time Frame: Week 5

Hunger/fullness will be assessed after breakfast and before lunch. The change in hunger ratings will provide data on how the breakfasts with different nutrient content affect hunger and fullness.

Changes in memory_Week 7

Time Frame: Week 7

The novel object test will be given to children at 5 timepoints during the study (once per week at baseline, week 1, week 3, week 5 and week 7). This test will assess any changes in memory after consuming breakfasts with different nutrient content.

Secondary Outcomes

  • Changes in weight/body fat_Week 3(Week 3)
  • Sleep habits_Baseline(Baseline)
  • Changes in weight/body fat_Week 1(Week 1)
  • Assessing children's usual breakfast habits(Baseline)
  • Changes in weight/body fat_Week 5(Week 5)
  • Changes in weight/body fat_Week 7(Week 7)
  • Sleep habits_Week 7(Week 7)
  • Changes in weight/body fat_Baseline(Baseline)
  • Sleep habits_Week 1(Week 1)
  • Sleep habits_Week 3(Week 3)
  • Sleep habits_Week 5(Week 5)

Study Sites (1)

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