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Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02122224
Enrollment
40
Registered
2014-04-24
Start date
2013-12-31
Completion date
2014-05-31
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lack of Satiety, Dietary Modification, Memory Deficits, Obesity

Keywords

satiety, satiation, diet quality, memory, obesity, protein, fiber

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.

Interventions

OTHERHigh fiber breakfast

Breakfast will contain 10-11g fiber.

Breakfast will contain 19-20g of protein.

OTHERHigh Protein/High Fiber Breakfast

Breakfast will include 19-22g of protein and 10-12g of fiber.

Sponsors

Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in memory_Week 7Week 7The 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_BaselineBaselineFood 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_BaselinebaselineThe 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 3Week 3Hunger/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.
Change in reports of hunger/fullness_Week 5Week 5Hunger/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.
Change in reports of hunger/fullness_Week 7Week 7Hunger/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 1Week 1Food 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.
Diet Quality_Week 3Week 3Food 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.
Diet Quality_Week 5Week 5Food 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 1Week 1The 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.
Changes in memory_Week 3Week 3The 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.
Changes in memory_Week 5Week 5The 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 7Week 7Food 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_BaselineBaselineHunger/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.

Secondary

MeasureTime frameDescription
Assessing children's usual breakfast habitsBaselineA 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.
Changes in weight/body fat_Week 1Week 1This 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.
Changes in weight/body fat_Week 3Week 3This 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.
Changes in weight/body fat_Week 5Week 5This 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.
Changes in weight/body fat_Week 7Week 7This 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.
Sleep habits_BaselineBaselineParents 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.
Sleep habits_Week 1Week 1Parents 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.
Sleep habits_Week 3Week 3Parents 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.
Sleep habits_Week 5Week 5Parents 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.
Sleep habits_Week 7Week 7Parents 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.
Changes in weight/body fat_BaselineBaselineThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026