HungerNCT03861208
Hunger and Learning Study in Preschoolers
A study testing diet and usual diet in people with Hunger and Ingestive Behavior, run by University of Virginia at 1 site in United States.
Trial summary
This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Hunger, Ingestive Behavior, Obesity
- What is being tested?
- diet and usual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 15 May 2024
- 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 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
Who cannot join
- no food allergies
- no medications that affect behavior/learning/appetite
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
Official title: Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old
This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. Data are collected at the Diet and Nutrition (DAN) laboratory on repeated study days (8am - 4 pm).
Read the detailed description
The investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. If preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. This study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch).
An important secondary outcome related to children's feelings of hunger is their ability to learn. Currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. This study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (Kranz S.et al. "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 doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (HTKS, KRISP, Stroop-style tasks, Woodcock Johnson vocabulary test, DCCS, and curisoty measures.)
- Conditions
- Hunger, Ingestive Behavior, Obesity, Food Preferences
- Being tested
- diet, usual diet
- Medical subject headings
- Feeding Behavior, Obesity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietOther
Also called High protein high fiber
foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial
usual dietOther
foods representing the usually provided foods at childcare are offered
| Study group | Role | What they receive |
|---|---|---|
| diet | Experimental | high fiber high protein foods served in childcare centers are offered for meals and snacks Receives: Other: diet |
| usual diet | Other | foods representing the usual diet in childcare centers are offered for meals and snacks Receives: Other: usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
hunger/fullness 120 minutes postprandial using "children's hunger scale"
hunger/fullness scale. change in children's perceived hunger and fullness on an age-appropriate scale: children respond to the question of "are you hungry or full" (coded hungry (1 or 2) or full (3 or 4)) followed by "are you very hungry( or full) or just a little hungry (or full)" coded as 1=very hungry, 2=a little hungry, 3- a little full, 4=very full, thus leading to a 4-point likert scale (from 1 to 4 with 1 being "very hungry" and 4 being "very full"). The development of the scale and its use are published by Kranz S. et al, Journal of Nutrition, 2017.
Measured: change on hunger/fullness scale from pre-lunch to 2-hours post lunch
salivary ghrelin levels
change in salivary ghrelin levels will be measured
Measured: change in salivary ghrelin from pre-lunch to 2-hours post lunch
Secondary outcomes (5)
learning (working memory)
Head Toes Knee and Shoulders test
Measured: change from pre-lunch to 2-hours post lunch
physical activity level
children will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days
Measured: through study completion, on average of 8 weeks
liking of food
children will rate the foods provided using an age-appropriate visual (smiley faces) response coded as "like"(smiling face), "neutral" (face with straight line as mouth(, and "don't like" (face with tongue sticking out).
Measured: through study completion, on average of 8 weeks
anthropometric data
measured height and weight to calculate CDC BMI-for-age percentiles of body weight status
Measured: at baseline
systolic and diastolic blood pressure
measured systolic and diastolic blood pressure
Measured: through study completion, on average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Jul 2018
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HungerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Kranz, PhD, RDN, University of Virginia
- Investigators
- Sibylle Kranz, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861208
- Sponsor's protocol ID
- SBS 2018007700
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 28077732Kranz S, Marshall YW, Wight A, Bordi PL, Kris-Etherton PM. Liking and consumption of high-fiber snacks in preschool-age children. Food Quality and Preference 22: 486-489, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old
- ClinicalTrials.gov ID
- NCT03861208
- Acronym / sponsor ID
- SBS 2018007700
- Conditions
- Hunger, Ingestive Behavior, Obesity, Food Preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 4 Mar 2019 (actual)
- 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.
This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. Data are collected at the Diet and Nutrition (DAN) laboratory on repeated study days (8am - 4 pm).
Detailed description
The investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. If preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. This study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch).
An important secondary outcome related to children's feelings of hunger is their ability to learn. Currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. This study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (Kranz S.et al. "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 doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (HTKS, KRISP, Stroop-style tasks, Woodcock Johnson vocabulary test, DCCS, and curisoty measures.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet | Experimental | Other: diethigh fiber high protein foods served in childcare centers are offered for meals and snacks |
| usual diet | Other | Other: usual dietfoods representing the usual diet in childcare centers are offered for meals and snacks |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children
Key exclusion criteria (2 listed)
- no food allergies
- no medications that affect behavior/learning/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 |
|---|---|---|
| dietAlso: High protein high fiberfoods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial | Other | diet |
| usual dietfoods representing the usually provided foods at childcare are offered | Other | usual diet |
Primary outcome
hunger/fullness 120 minutes postprandial using "children's hunger scale"
Time frame: change on hunger/fullness scale from pre-lunch to 2-hours post lunch
hunger/fullness scale. change in children's perceived hunger and fullness on an age-appropriate scale: children respond to the question of "are you hungry or full" (coded hungry (1 or 2) or full (3 or 4)) followed by "are you very hungry( or full) or just a little hungry (or full)" coded as 1=very hungry, 2=a little hungry, 3- a little full, 4=very full, thus leading to a 4-point likert scale (from 1 to 4 with 1 being "very hungry" and 4 being "very full"). The development of the scale and its use are published by Kranz S. et al, Journal of Nutrition, 2017.
salivary ghrelin levels
Time frame: change in salivary ghrelin from pre-lunch to 2-hours post lunch
change in salivary ghrelin levels will be measured
5 secondary outcomes
learning (working memory)
Time frame: change from pre-lunch to 2-hours post lunch
physical activity level
Time frame: through study completion, on average of 8 weeks
liking of food
Time frame: through study completion, on average of 8 weeks
anthropometric data
Time frame: at baseline
systolic and diastolic blood pressure
Time frame: through study completion, on average of 8 weeks
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 18 Jun 2024.
- Background: 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.
- BackgroundKranz S, Marshall YW, Wight A, Bordi PL, Kris-Etherton PM. Liking and consumption of high-fiber snacks in preschool-age children. Food Quality and Preference 22: 486-489, 2011.
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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 principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet and usual diet in people with Hunger and Ingestive Behavior, run by University of Virginia 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 2 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 18 Jun 2024. 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?
hunger/fullness 120 minutes postprandial using "children's hunger scale" (time frame: change on hunger/fullness scale from pre-lunch to 2-hours post lunch). The study lists 2 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 NCT03861208, which also lists 2 linked publications.
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 18 Jun 2024.