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临床试验/NCT02122224
NCT02122224已完成不适用

Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory

Purdue University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in reports of hunger/fullness_Baseline

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: High fiber breakfast (Other)

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.

干预措施: High Protein Breakfast (Other)

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.

干预措施: High Protein/High Fiber Breakfast (Other)

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.

干预措施: High fiber breakfast (Other)

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.

干预措施: High Protein Breakfast (Other)

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.

干预措施: High Protein/High Fiber Breakfast (Other)

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.

干预措施: High fiber breakfast (Other)

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.

干预措施: High Protein Breakfast (Other)

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.

干预措施: High Protein/High Fiber Breakfast (Other)

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.

干预措施: High fiber breakfast (Other)

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.

干预措施: High Protein Breakfast (Other)

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.

干预措施: High Protein/High Fiber Breakfast (Other)

结局指标

主要结局

Change in reports of hunger/fullness_Baseline

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne Campbell

Prof. Nutrition Science

Purdue University

研究点 (2)

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