Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
NCT Number: NCT06548828
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy|Glucose Intolerance During Pregnancy|Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation
Interventions: BEHAVIORAL: NNS Restriction Intervention|BEHAVIORAL: Control Intervention
Sponsor: George Washington University
Collaborators: Children's Hospital Los Angeles|Children's National Research Institute|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: FEMALE
Age: ADULT
Enrollment: 324
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-19
Completion Date: 2029-02
Locations: The George Washington University, Washington, District of Columbia, 20037, United States

Summary:
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/or 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.

Primary Outcome Measures: Infants' adiposity, Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or 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|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
Secondary Outcome Measures: Infants' adiposity, Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation influences infants' adiposity, which is known to be predictive of potential future obesity risk by assess infants' fat mass percent., At 1 month of age|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., At 28 weeks gestation|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., At 1 month postpartum|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., At 6 months postpartum|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/water mixture, At 28 weeks gestation|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/water mixture., At 28 weeks gestation|Infants' gestational age, Determine gestational age at birth., At birth|Infants' birthweight, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight., At birth|Infants' birthweight based on gestational age, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight for gestational age., At birth|Infants' age-sex specific percentile, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' height and weight for age by assessing age-sex specific percentile., At 1 month of age|Infants' age-sex specific percentile, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' height and weight for age by assessing age-sex specific percentile., At 6 months of age|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)., At 28 weeks gestation|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)., At 28 weeks gestation|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., At 28 weeks gestation|Mothers' energy intake, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum., At 1 month postpartum|Mothers' energy intake, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum., At 6 months postpartum
Other Outcome Measures: Infants' gut microbiome composition, Determine the effects of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation on the composition of the infant gut microbiome as it changes dramatically over the first few years of life by evaluating relative abundance of Firmicutes, Akkermansia muciniphila, Bifidobacterium, Lactobacillus, Proteobacteria present in stool specimens., At 1 month of age|Infants' gut microbiome composition, Determine the effects of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation on the composition of the infant gut microbiome as it changes dramatically over the first few years of life by evaluating relative abundance of Firmicutes, Akkermansia muciniphila, Bifidobacterium, Lactobacillus, Proteobacteria present in stool specimens., At 6 months of age|Mothers' gestational weight gain, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' total weight gain during pregnancy by assessing maternal gestational weight gain (GWG)., At delivery|Mothers' waist circumference, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' adiposity by assessing waist circumference (WC)., At 1 month postpartum|Mothers' waist circumference, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' adiposity by assessing waist circumference (WC)., At 6 months postpartum|Mothers' body composition during pregnancy, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' body composition by assessing percent body fat., At 28 weeks gestation|Mothers' C-reactive protein (CRP) concentration, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations., At 28 weeks gestation|Mothers' C-reactive protein (CRP) concentration, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations., At 1 month postpartum|Mothers' C-reactive protein (CRP) concentration, Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and postpartum on mothers' fasting concentration of C-reactive protein (CRP) concentrations., At 6 months postpartum