Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
- Conditions
- Gestational Diabetes Mellitus in PregnancyGlucose Intolerance During PregnancyNon-nutritive Sweeteners Consumption in Pregnancy And/or Lactation
- Interventions
- Behavioral: NNS Restriction InterventionBehavioral: Control Intervention
- Registration Number
- NCT06548828
- Lead Sponsor
- George Washington University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 324
- Pregnant
- ≤ 16 weeks' gestation
- Singleton pregnancy
- Report frequent NNS beverage consumption (≥ 7 servings/week)
- 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.
- Physical or mental concerns preventing study participation;
- Medication (e.g., metformin; GLP-1 agomists) 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/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNS Restriction in Lactation (Group 2) Control Intervention Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation. NNS Restriction in Pregnancy and Lactation (Group 3) NNS Restriction Intervention Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation. Control (Group 1) Control Intervention Participants in this arm will continue their usual consumption of NNS throughout pregnancy and lactation without any intervention. They will not receive any specific NNS-restriction intervention. NNS Restriction in Lactation (Group 2) NNS Restriction Intervention Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
- Primary Outcome Measures
Name Time Method Mothers' incremental area under glucose response curves At 28 weeks gestation 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.
Infants' adiposity At 6 months of age 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.
- Secondary Outcome Measures
Name Time Method Infants' adiposity At 1 month of age 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.
Mothers' fasting blood glucose concentration At 6 months postpartum Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy on mothers' metabolic and inflammatory biomarkers by assessing fasting glucose concentrations.
Mothers' 60 minute glucose concentration At 28 weeks gestation 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
Infants' gestational age At birth Determine gestational age at birth.
Infants' birthweight At birth Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during pregnancy and/or lactation on infants' growth by assessing birth weight.
Mothers' assessment of insulin resistance At 28 weeks gestation 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).
Mothers' 120 minute glucose concentration At 28 weeks gestation 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.
Infants' age-sex specific percentile At 6 months of age 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.
Mothers' insulin sensitivity index At 28 weeks gestation 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).
Infants' birthweight based on gestational age At birth 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.
Mothers' energy intake At 6 months postpartum Determine effects of restricting usual non-nutritive sweeteners (NNS) consumption during lactation on mothers' mean energy intake from dietary recalls during postpartum.
Trial Locations
- Locations (1)
The George Washington University
🇺🇸Washington, District of Columbia, United States