Lack of SatietyNCT02122224
Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory
A study testing High fiber breakfast, High Protein Breakfast and High Protein/High Fiber Breakfast in people with Lack of Satiety and Dietary Modification, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Lack of Satiety, Dietary Modification, Memory Deficits
- What is being tested?
- High fiber breakfast, High Protein Breakfast and High Protein/High Fiber Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-5 year old children attending Head Start centers in Lafayette, IN. Males and females of all racial and ethnic background are included.
Who cannot join
- No digestive disorders, food allergies, or kidney disease. Children cannot be taking medication that would affect appetite.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bauer Family Resources (Head Start)
Lafayette, Indiana, 47902
About this study
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.
- Conditions
- Lack of Satiety, Dietary Modification, Memory Deficits, Obesity
- Being tested
- High fiber breakfast, High Protein Breakfast, High Protein/High Fiber Breakfast
- Keywords
- satiety, satiation, diet quality, memory, obesity, protein, fiber
- Medical subject headings
- Memory Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fiber breakfastOther
Breakfast will contain 10-11g fiber.
High Protein BreakfastOther
Breakfast will contain 19-20g of protein.
High Protein/High Fiber BreakfastOther
Breakfast will include 19-22g of protein and 10-12g of fiber.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: High fiber breakfast; Other: High Protein Breakfast; Other: 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. Receives: Other: High fiber breakfast; Other: High Protein Breakfast; Other: 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. Receives: Other: High fiber breakfast; Other: High Protein Breakfast; Other: 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. Receives: Other: High fiber breakfast; Other: High Protein Breakfast; Other: High Protein/High Fiber Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 7
Secondary outcomes (11)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Week 1
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.
Measured: Week 3
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.
Measured: Week 5
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.
Measured: Week 7
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.
Measured: Baseline
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.
Measured: Week 1
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.
Measured: Week 3
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.
Measured: Week 5
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.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lack of SatietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Sibylle Kranz, PhD, RD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122224
- Sponsor's protocol ID
- PU-IRB1310014050
- Other IDs
- 1310014050
- Status last verified
- Jan 2018
- First submitted
- 22 Apr 2014
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28077732
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory
- ClinicalTrials.gov ID
- NCT02122224
- Acronym / sponsor ID
- PU-IRB1310014050
- Conditions
- Lack of Satiety, Dietary Modification, Memory Deficits, Obesity
- Keywords
- satiety, satiation, diet quality, memory, obesity, protein, fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: High fiber breakfast, Other: High Protein Breakfast, Other: High Protein/High Fiber BreakfastGroups 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. |
| Group 2 | Experimental | Other: High fiber breakfast, Other: High Protein Breakfast, Other: High Protein/High Fiber BreakfastGroups 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. |
| Group 3 | Experimental | Other: High fiber breakfast, Other: High Protein Breakfast, Other: High Protein/High Fiber BreakfastGroups 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. |
| Group 4 | Experimental | Other: High fiber breakfast, Other: High Protein Breakfast, Other: High Protein/High Fiber BreakfastGroups 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. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4-5 year old children attending Head Start centers in Lafayette, IN. Males and females of all racial and ethnic background are included.
Key exclusion criteria (1 listed)
- No digestive disorders, food allergies, or kidney disease. Children cannot be taking medication that would affect appetite.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fiber breakfastBreakfast will contain 10-11g fiber. | Other | Group 1, Group 2, Group 3, Group 4 |
| High Protein BreakfastBreakfast will contain 19-20g of protein. | Other | Group 1, Group 2, Group 3, Group 4 |
| High Protein/High Fiber BreakfastBreakfast will include 19-22g of protein and 10-12g of fiber. | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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_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.
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 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.
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.
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_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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
Changes in weight/body fat_Baseline
Time frame: Baseline
Assessing children's usual breakfast habits
Time frame: Baseline
Changes in weight/body fat_Week 1
Time frame: Week 1
Changes in weight/body fat_Week 3
Time frame: Week 3
Changes in weight/body fat_Week 5
Time frame: Week 5
Changes in weight/body fat_Week 7
Time frame: Week 7
Sleep habits_Baseline
Time frame: Baseline
Sleep habits_Week 1
Time frame: Week 1
Sleep habits_Week 3
Time frame: Week 3
Sleep habits_Week 5
Time frame: Week 5
Sleep habits_Week 7
Time frame: Week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Derived from this study: PubMed 28077732Kranz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibylle Kranz, PhD, RD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fiber breakfast, High Protein Breakfast and High Protein/High Fiber Breakfast in people with Lack of Satiety and Dietary Modification, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reports of hunger/fullness_Baseline (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.