[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06882252":3,"trial-entities:NCT06882252":109,"trial-summary:NCT06882252":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":41,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":79,"locations":81,"central_contacts":97,"overall_officials":99,"references":100,"see_also_links":108},"NCT06882252","HSR231601","Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes","Increasing Lean Protein Intake in Preschool-age Children","RECRUITING","2025-12-31","2025-03","2025-03-18","2025-02-08","Sibylle Kranz, PhD, RDN","OTHER",false,"The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger\u002Fsatiety based on consuming a snack and a meal (lunch\u002Fdinner) 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.",null,[19],"Diet Modification",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Low glycemic index diet","Replacement of typical meal\u002Fsnack with lean pork containing meal\u002Fsnack",[32],"Intervention",[34,38],{"measure":35,"description":36,"timeFrame":37},"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.","6 study days",{"measure":39,"description":40,"timeFrame":37},"Hunger\u002FSatiety 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",[42,46,49,52,55,58],{"measure":43,"description":44,"timeFrame":45},"Blood pressure","Measured blood pressure 60 minutes after the meal.","60 minutes after the meal.",{"measure":47,"description":48,"timeFrame":37},"Blood glucose","Blood glucose concentration 60 minutes after the meal. Measured using finger-stick and glucometer reading.",{"measure":50,"description":51,"timeFrame":37},"Executive function: focus and short-term memory","Using the \"track-it\" game, children respond to visual cues.",{"measure":53,"description":54,"timeFrame":37},"Executive function: memory and focus","Using KRISP, children respond to visual cues to assess focus and short-term memory",{"measure":56,"description":57,"timeFrame":37},"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.",{"measure":59,"description":60,"timeFrame":37},"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.","ALL","2 Years","5 Years",true,{"inclusion":66,"exclusion":71,"raw_text":78},[67,68,69,70],"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\u002F religious reason to abstain from to consuming pork",[72,73,74,75,76,77],"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\u002Freligious preferences that exclude consumption of pork","Inclusion Criteria:\n\n* child 2-5 years old\n\nParent participants:\n\n* Parents of at least one child aged 2-5 years old\n* Parents can communicate in English.\n* Parents in households who do not have a cultural\u002F religious reason to abstain from to consuming pork\n\nExclusion Criteria:\n\n* Child participants:\n* Food allergies\n* Taking medication that affects food intake (such as stimulant medications),\n* Children with diabetes or impaired glucose control.\n* Children with digestive disease (such as Crohn's)\n* Dietary\u002Freligious preferences that exclude consumption of pork\n\nParent participants:\n\n\\- Dietary\u002Freligious preferences that exclude consumption of pork",[80],"CHILD",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"University of Virginia","Charlottesville","Virginia","22903","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Sibylle Kranz, PhD, RD","CONTACT","434-924-7904","sibylle.kranz@virginia.edu",{"lat":95,"lon":96},38.02931,-78.47668,[98],{"name":90,"role":91,"phone":92,"email":93},[],[101,105],{"pmid":102,"type":103,"citation":104},"36029824","BACKGROUND","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\u002Fj.jpeds.2022.08.033. Epub 2022 Aug 24.",{"pmid":106,"type":103,"citation":107},"16022763","Mikkila 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\u002Fbjn20051418.",[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Healthy",[],{"nct_id":4,"found":64,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This interventional study plans to enroll 20 participants. It compares a low glycemic index diet (lean pork meals\u002Fsnacks) to typical childcare center food.","completed","Lean Protein Intake and Cognition in Preschoolers","This study is looking at how eating lean protein affects preschool-aged children. Researchers want to see if replacing typical snacks and meals with lean pork options, which have a lower glycemic index (a measure of how quickly food raises blood sugar), changes how children recognize feelings of hunger and fullness. The study is for children aged 2 to 5 years old whose parents can speak English and do not have religious or cultural reasons to avoid pork. Children with food allergies or who take medications that affect food intake cannot participate. The study aims to enroll 20 participants.","The primary endpoints, glycemic load and hunger\u002Fsatiety, are measured over 6 study days. This suggests a short follow-up period.",98,"Participants will have their diet's glycemic load measured over 6 study days. They will also self-report hunger and satiety on a 4-point scale over 6 study days.","Not stated in the trial record.",[],"v2"]