Diet ModificationNCT06882252
Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes
A study testing Low glycemic index diet in people with Diet Modification, run by Sibylle Kranz, PhD, RDN at 1 site in United States.
Trial summary
The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Low glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child 2-5 years old
- Parent participants:
- Parents of at least one child aged 2-5 years old
- Parents can communicate in English.
- Parents in households who do not have a cultural/ religious reason to abstain from to consuming pork
Who cannot join
- Child participants:
- Food allergies
- Taking medication that affects food intake (such as stimulant medications),
- Children with diabetes or impaired glucose control.
- Children with digestive disease (such as Crohn's)
- Dietary/religious preferences that exclude consumption of pork
- Parent participants:
- Dietary/religious preferences that exclude consumption of pork
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Sibylle Kranz, PhD, RD, 434-924-7904, sibylle.kranz@virginia.edu
About this study
Official title: Increasing Lean Protein Intake in Preschool-age Children
The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.
- Conditions
- Diet Modification
- Being tested
- Low glycemic index diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index dietOther
Replacement of typical meal/snack with lean pork containing meal/snack
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Diet modification: Low glycemic index diet Meal and snack are made with lean pork to reduce glycemic index of food consumed. Receives: Other: Low glycemic index diet |
| Control | No intervention | Typically consumed meal and snack; high glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic load of diet
Estimated intake of glycemic load of meals and snacks consumed. Plate-waste method will be used to calculate total energy, GI, GL consumed at each meal and snack using disaggregated intake (in grams) and analysis using Nutrient Data System for Research (NDS-R) software.
Measured: 6 study days
Hunger/Satiety self-reported on 4-point scale
Self-reported feelings of hunger or fullness using: 1 = Very hungry, 2 = A little hungry, 3 = A little full, 4 = Very full
Measured: 6 study days
Secondary outcomes (6)
Blood pressure
Measured blood pressure 60 minutes after the meal.
Measured: 60 minutes after the meal.
Blood glucose
Blood glucose concentration 60 minutes after the meal. Measured using finger-stick and glucometer reading.
Measured: 6 study days
Executive function: focus and short-term memory
Using the "track-it" game, children respond to visual cues.
Measured: 6 study days
Executive function: memory and focus
Using KRISP, children respond to visual cues to assess focus and short-term memory
Measured: 6 study days
Executive Function: Focus and Concentration
Using the "peg it" game, children are asked to use a small wooden hammer to tab the table surface. First, they repeat how many tabs the researcher demonstrated (1 or 2), then they are asked to tab the opposite, so if the researcher tabs once, they tab twice and when the researcher tabs twice, they tab once.
Measured: 6 study days
Executive Function: Concentration
Using the happy-sad game, children sort small playing cards with happy or sad faces on them to align with the verbal cue of the researcher, or to put down the opposite card.
Measured: 6 study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start8 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Diet ModificationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibylle Kranz, PhD, RDN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibylle Kranz, PhD, RDN, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882252
- Sponsor's protocol ID
- HSR231601
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot and feasibility study and subjects may be identified if individual participant data is shared.
Publications
Varley BJ, Nasir RF, Skilton MR, Craig ME, Gow ML. Early Life Determinants of Vascular Structure in Fetuses, Infants, Children, and Adolescents: A Systematic Review and Meta-Analysis. J Pediatr. 2023 Jan;252:101-110.e9. doi: 10.1016/j.jpeds.2022.08.033. Epub 2022 Aug 24.
PubMed 36029824Mikkila V, Rasanen L, Raitakari OT, Pietinen P, Viikari J. Consistent dietary patterns identified from childhood to adulthood: the cardiovascular risk in Young Finns Study. Br J Nutr. 2005 Jun;93(6):923-31. doi: 10.1079/bjn20051418.
PubMed 16022763
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Lean Protein Intake in Preschool-age Children
- ClinicalTrials.gov ID
- NCT06882252
- Acronym / sponsor ID
- HSR231601
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sibylle Kranz, PhD, RDNUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (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.
The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Low glycemic index dietDiet modification: Low glycemic index diet Meal and snack are made with lean pork to reduce glycemic index of food consumed. |
| Control | No intervention | –Typically consumed meal and snack; high glycemic index |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- child 2-5 years old
- Parents of at least one child aged 2-5 years old
- Parents can communicate in English.
- Parents in households who do not have a cultural/ religious reason to abstain from to consuming pork
Key exclusion criteria (8 listed)
- Child participants:
- Food allergies
- Taking medication that affects food intake (such as stimulant medications),
- Children with diabetes or impaired glucose control.
- Children with digestive disease (such as Crohn's)
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 |
|---|---|---|
| Low glycemic index dietReplacement of typical meal/snack with lean pork containing meal/snack | Other | Intervention |
Primary outcome
Glycemic load of diet
Time frame: 6 study days
Estimated intake of glycemic load of meals and snacks consumed. Plate-waste method will be used to calculate total energy, GI, GL consumed at each meal and snack using disaggregated intake (in grams) and analysis using Nutrient Data System for Research (NDS-R) software.
Hunger/Satiety self-reported on 4-point scale
Time frame: 6 study days
Self-reported feelings of hunger or fullness using: 1 = Very hungry, 2 = A little hungry, 3 = A little full, 4 = Very full
6 secondary outcomes
Blood pressure
Time frame: 60 minutes after the meal.
Blood glucose
Time frame: 6 study days
Executive function: focus and short-term memory
Time frame: 6 study days
Executive function: memory and focus
Time frame: 6 study days
Executive Function: Focus and Concentration
Time frame: 6 study days
Executive Function: Concentration
Time frame: 6 study days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 36029824Varley BJ, Nasir RF, Skilton MR, Craig ME, Gow ML. Early Life Determinants of Vascular Structure in Fetuses, Infants, Children, and Adolescents: A Systematic Review and Meta-Analysis. J Pediatr. 2023 Jan;252:101-110.e9. doi: 10.1016/j.jpeds.2022.08.033. Epub 2022 Aug 24.
- Background: PubMed 16022763Mikkila V, Rasanen L, Raitakari OT, Pietinen P, Viikari J. Consistent dietary patterns identified from childhood to adulthood: the cardiovascular risk in Young Finns Study. Br J Nutr. 2005 Jun;93(6):923-31. doi: 10.1079/bjn20051418.
- Individual participant dataSharing planned: No. This is a small pilot and feasibility study and subjects may be identified if individual participant data is shared.
Related trials for Diet Modification
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index diet in people with Diet Modification, run by Sibylle Kranz, PhD, RDN 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sibylle Kranz, PhD, RD (434-924-7904, sibylle.kranz@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic load of diet (time frame: 6 study days). 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 NCT06882252, 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 Mar 2025.