NCT02122224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

April 22, 2014

Last Update Submit

January 9, 2018

Conditions

Lack of SatietyDietary ModificationMemory DeficitsObesity

Keywords

satietysatiationdiet qualitymemoryobesityproteinfiber

Outcome Measures

Primary Outcomes (14)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (11)

  • Changes in weight/body fat_Baseline

    Baseline

  • Assessing children's usual breakfast habits

    Baseline

  • Changes in weight/body fat_Week 1

    Week 1

  • Changes in weight/body fat_Week 3

    Week 3

  • Changes in weight/body fat_Week 5

    Week 5

  • +6 more secondary outcomes

Study Arms (4)

Group 1

EXPERIMENTAL

Groups will rotate through each of the 3 intervention breakfasts as well as the "usual" breakfast supplied at the preschool for a total of 4 weeks.

Other: High fiber breakfastOther: High Protein BreakfastOther: High Protein/High Fiber Breakfast

Group 2

EXPERIMENTAL

Groups will rotate through each of the 3 intervention breakfasts as well as the "usual" breakfast supplied at the preschool for a total of 4 weeks.

Other: High fiber breakfastOther: High Protein BreakfastOther: High Protein/High Fiber Breakfast

Group 3

EXPERIMENTAL

Groups will rotate through each of the 3 intervention breakfasts as well as the "usual" breakfast supplied at the preschool for a total of 4 weeks.

Other: High fiber breakfastOther: High Protein BreakfastOther: High Protein/High Fiber Breakfast

Group 4

EXPERIMENTAL

Groups will rotate through each of the 3 intervention breakfasts as well as the "usual" breakfast supplied at the preschool for a total of 4 weeks.

Other: High fiber breakfastOther: High Protein BreakfastOther: High Protein/High Fiber Breakfast

Interventions

High fiber breakfastOTHER

Breakfast will contain 10-11g fiber.

Group 1Group 2Group 3Group 4
High Protein BreakfastOTHER

Breakfast will contain 19-20g of protein.

Group 1Group 2Group 3Group 4
High Protein/High Fiber BreakfastOTHER

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

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauer Family Resources (Head Start)

Lafayette, Indiana, 47902, United States

Location

Related Publications (1)

  • 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.

    PMID: 28077732DERIVED

MeSH Terms

Conditions

Memory DisordersObesity

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Sibylle Kranz, PhD, RD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Nutrition Science

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 24, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)