[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06548828":3,"trial-entities:NCT06548828":146,"trial-summary:NCT06548828":151},{"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":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":50,"secondary_outcomes":59,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":15,"eligibility_criteria":104,"std_ages":123,"locations":125,"central_contacts":141,"overall_officials":143,"references":144,"see_also_links":145},"NCT06548828","SweetPea","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)","RECRUITING","2029-02-01","2026-02","2026-02-18","2024-08-19","George Washington University","OTHER",true,"The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and\u002For lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.",null,[19,20,21],"Gestational Diabetes Mellitus in Pregnancy","Glucose Intolerance During Pregnancy","Non-nutritive Sweeteners Consumption in Pregnancy and\u002For Lactation",[23,24,25,26,27,28,29],"Non-nutritive sweeteners (NNS)","Pregnancy","Lactation","Infant fat mass","Gestational diabetes (GDM)","Glucose tolerance","PeaPod","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},324,"ESTIMATED",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","NNS Restriction Intervention","Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy\u002Flactation may have unfavorable effects on infants' adiposity and health.\n\nProvide detailed handouts, which will include a list of specific foods and beverages containing NNS to avoid during the study and summarize current scientific evidence on the metabolic and health effects of NNS.\n\nEmphasize that sugar is not the best alternative to NNS, and that the participant should drink still water, sparkling water, flavored waters with no added sweeteners, or unsweetened tea instead.\n\nBi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages.\n\nAutomated text messages will also be sent to mothers once per week with reminders that they should avoid NNS",[43,44],"NNS Restriction in Lactation (Group 2)","NNS Restriction in Pregnancy and Lactation (Group 3)",{"type":39,"name":46,"description":47,"armGroupLabels":48},"Control Intervention","Counsel about best practices for home safety and babyproofing.\n\nProvide a detailed booklet to take home, which will provide information about home safety and baby proofing.\n\nEducate about common causes of accidental infant and young child injuries or death.\n\nAutomated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.",[49,43],"Control (Group 1)",[51,55],{"measure":52,"description":53,"timeFrame":54},"Infants' adiposity","Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and\u002For lactation influences infants' adiposity, which is known to be predictive of potential future obesity risk by assess infants' fat mass percent.","At 6 months of age",{"measure":56,"description":57,"timeFrame":58},"Mothers' incremental area under glucose response curves","Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.","At 28 weeks gestation",[60,62,65,67,69,72,75,79,82,85,88,89,92,95,98,100],{"measure":52,"description":53,"timeFrame":61},"At 1 month of age",{"measure":63,"description":64,"timeFrame":58},"Mothers' fasting blood glucose concentration","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.",{"measure":63,"description":64,"timeFrame":66},"At 1 month postpartum",{"measure":63,"description":64,"timeFrame":68},"At 6 months postpartum",{"measure":70,"description":71,"timeFrame":58},"Mothers' 60 minute glucose concentration","Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the blood glucose levels 60 minutes following ingestion of a standard glucose\u002Fwater mixture",{"measure":73,"description":74,"timeFrame":58},"Mothers' 120 minute glucose concentration","Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the blood glucose levels 120 minutes following ingestion of a standard glucose\u002Fwater mixture.",{"measure":76,"description":77,"timeFrame":78},"Infants' gestational age","Determine gestational age at birth.","At birth",{"measure":80,"description":81,"timeFrame":78},"Infants' birthweight","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and\u002For lactation on infants' growth by assessing birth weight.",{"measure":83,"description":84,"timeFrame":78},"Infants' birthweight based on gestational age","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and\u002For lactation on infants' growth by assessing birth weight for gestational age.",{"measure":86,"description":87,"timeFrame":61},"Infants' age-sex specific percentile","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and\u002For lactation on infants' height and weight for age by assessing age-sex specific percentile.",{"measure":86,"description":87,"timeFrame":54},{"measure":90,"description":91,"timeFrame":58},"Mothers' insulin sensitivity index","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on maternal insulin sensitivity by assessing composite whole-body insulin sensitivity index (WBISI).",{"measure":93,"description":94,"timeFrame":58},"Mothers' assessment of insulin resistance","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on maternal insulin sensitivity by assessing homeostasis model assessment of insulin resistance (HOMA-IR).",{"measure":96,"description":97,"timeFrame":58},"Mothers' energy intake","Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during pregnancy.",{"measure":96,"description":99,"timeFrame":66},"Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.",{"measure":96,"description":99,"timeFrame":68},"FEMALE","18 Years","45 Years",{"inclusion":105,"exclusion":114,"raw_text":122},[106,107,108,109,110,111,112,113],"Pregnant","≤ 16 weeks gestation","Singleton pregnancy","Report frequent NNS beverage consumption (≥ 7 servings\u002Fweek)","18-45 years of age","Able to read English at a 5th grade level; and","Intend to breastfeed for at least the first 6 months of life.","For infants: The mother must be enrolled and provide assent for the infant to participate.",[115,116,117,118,119,120,121],"Physical or mental concerns preventing study participation;","Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;","Tobacco or drug use during pregnancy;","Alcohol consumption (\\>1 drink per week) during pregnancy;","Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;","Known suspected\u002Fconfirmed genetic fetal abnormalities or suspected or known congenital birth defects.","History of prior gastric bypass surgery.","Inclusion Criteria:\n\n* Pregnant\n* ≤ 16 weeks gestation\n* Singleton pregnancy\n* Report frequent NNS beverage consumption (≥ 7 servings\u002Fweek)\n* 18-45 years of age\n* Able to read English at a 5th grade level; and\n* Intend to breastfeed for at least the first 6 months of life.\n* For infants: The mother must be enrolled and provide assent for the infant to participate.\n\nExclusion Criteria:\n\n* Physical or mental concerns preventing study participation;\n* Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;\n* Tobacco or drug use during pregnancy;\n* Alcohol consumption (\\>1 drink per week) during pregnancy;\n* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;\n* Known suspected\u002Fconfirmed genetic fetal abnormalities or suspected or known congenital birth defects.\n* History of prior gastric bypass surgery.",[124],"ADULT",[126],{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":131,"contacts":132,"geoPoint":138},"The George Washington University","Washington D.C.","District of Columbia","20037","United States",[133],{"name":134,"role":135,"phone":136,"email":137},"Allison C Sylvetsky, PhD","CONTACT","202-994-5602","asylvets@gwu.edu",{"lat":139,"lon":140},38.89511,-77.03637,[142],{"name":134,"role":135,"phone":136,"email":137},[],[],[],{"nct_id":4,"conditions":147,"biomarkers":150},[148,149,24],"Gestational Diabetes","Glucose Intolerance",[],{"nct_id":4,"found":15,"summary":152,"prompt_version":162},{"design":153,"status":154,"heading":155,"summary":156,"follow_up":157,"word_count":158,"commitments":159,"compensation":160,"drugs_mentioned":161},"This interventional study plans to enroll 324 pregnant women who frequently consume non-nutritive sweeteners and will randomly assign them to either an NNS restriction group or a control group.","completed","Study on Non-nutritive Sweeteners in Pregnancy and Lactation","This study is looking at how consuming non-nutritive sweeteners (NNS) during pregnancy and breastfeeding might affect a baby's body fat and a mother's blood sugar. If you are pregnant, 18-45 years old, less than 16 weeks pregnant with one baby, and drink NNS beverages frequently (7 or more servings per week), you might be able to join. You should also be able to read English and plan to breastfeed for at least six months. Participants will either reduce their NNS intake or receive counseling on home safety. Researchers will measure your baby's body fat at 6 months of age and your blood sugar at 28 weeks of pregnancy to see if the intervention is successful. The current status of this study is unclear.","Infants' body fat will be measured at 6 months of age, and mothers' blood sugar will be measured at 28 weeks gestation.",123,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]