Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122224
• Other study ID #: PU-IRB1310014050
• Secondary ID: 1310014050
• Status: Completed
• Phase: N/A
• First received: April 22, 2014
• Last updated: January 9, 2018
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Modification
• Lack of Satiety
• Memory Deficits
• Memory Disorders
• Obesity

Intervention

Other:
• High fiber breakfast
Breakfast will contain 10-11g fiber.
• High Protein Breakfast
Breakfast will contain 19-20g of protein.
• High Protein/High Fiber Breakfast
Breakfast will include 19-22g of protein and 10-12g of fiber.

Locations

Country	Name	City	State
United States	Bauer Family Resources (Head Start)	Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reports of hunger/fullness_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.	Baseline
Primary	Diet Quality_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.	Baseline
Primary	Changes in memory_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.	baseline
Primary	Change in reports of hunger/fullness_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.	Week 3
Primary	Change in reports of hunger/fullness_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.	Week 5
Primary	Change in reports of hunger/fullness_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.	Week 7
Primary	Diet Quality_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.	Week 1
Primary	Diet Quality_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.	Week 3
Primary	Diet Quality_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.	Week 5
Primary	Diet Quality_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.	Week 7
Primary	Changes in memory_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.	Week 1
Primary	Changes in memory_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.	Week 3
Primary	Changes in memory_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.	Week 5
Primary	Changes in memory_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.	Week 7
Secondary	Changes in weight/body fat_Baseline	This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.	Baseline
Secondary	Assessing children's usual breakfast habits	A survey will be given to families asking questions about their child and families usual breakfast habits. This will be utilized to control for any fluctuations in breakfast consumption seen during the study.	Baseline
Secondary	Changes in weight/body fat_Week 1	This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.	Week 1
Secondary	Changes in weight/body fat_Week 3	This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.	Week 3
Secondary	Changes in weight/body fat_Week 5	This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.	Week 5
Secondary	Changes in weight/body fat_Week 7	This will be done to assess any changes in weight/body fat during the study. Anthropometrics will be done once during baseline, week 1, week 3, week 5 and week 7.	Week 7
Secondary	Sleep habits_Baseline	Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.	Baseline
Secondary	Sleep habits_Week 1	Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.	Week 1
Secondary	Sleep habits_Week 3	Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.	Week 3
Secondary	Sleep habits_Week 5	Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.	Week 5
Secondary	Sleep habits_Week 7	Parents will rate how their children slept the night before the memory test to control for any memory changes that might occur as a result of sleep changes.	Week 7