Clinical trial NCT06548828: Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes
Official title: Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Glucose Intolerance During Pregnancy
Non-nutritive Sweeteners Consumption in Pregnancy And/or Lactation
Keywords: Non-nutritive sweeteners (NNS)
Pregnancy
Lactation
Infant fat mass
Gestational diabetes (GDM)
Glucose tolerance
PeaPod
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: Children's National Research Institute
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-12
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* ≤ 16 weeks\&#39; 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.

Exclusion Criteria:

* 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 (\&gt;1 drink per week) during pregnancy;
* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn\&#39;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.

Primary outcomes:
measure: Infants' adiposity
timeFrame: At 6 months of age
measure: Mothers' incremental area under glucose response curves
timeFrame: At 28 weeks gestation
Secondary outcomes:
measure: Infants' adiposity
timeFrame: At 1 month of age
measure: Mothers' fasting blood glucose concentration
timeFrame: At 28 weeks gestation
measure: Mothers' fasting blood glucose concentration
timeFrame: At 1 month postpartum
measure: Mothers' fasting blood glucose concentration
timeFrame: At 6 months postpartum
measure: Mothers' 60 minute glucose concentration
timeFrame: At 28 weeks gestation
measure: Mothers' 120 minute glucose concentration
timeFrame: At 28 weeks gestation
measure: Infants' gestational age
timeFrame: At birth
measure: Infants' birthweight
timeFrame: At birth
measure: Infants' birthweight based on gestational age
timeFrame: At birth
measure: Infants' age-sex specific percentile
timeFrame: At 1 month of age
measure: Infants' age-sex specific percentile
timeFrame: At 6 months of age
measure: Mothers' insulin sensitivity index
timeFrame: At 28 weeks gestation
measure: Mothers' assessment of insulin resistance
timeFrame: At 28 weeks gestation
measure: Mothers' energy intake
timeFrame: At 28 weeks gestation
measure: Mothers' energy intake
timeFrame: At 1 month postpartum
measure: Mothers' energy intake
timeFrame: At 6 months postpartum
Other outcomes:
measure: Infants' gut microbiome composition
timeFrame: At 1 month of age
measure: Infants' gut microbiome composition
timeFrame: At 6 months of age
measure: Mothers' gestational weight gain
timeFrame: At delivery
measure: Mothers' waist circumference
timeFrame: At 1 month postpartum
measure: Mothers' waist circumference
timeFrame: At 6 months postpartum
measure: Mothers' body composition during pregnancy
timeFrame: At 28 weeks gestation
measure: Mothers' C-reactive protein (CRP) concentration
timeFrame: At 28 weeks gestation
measure: Mothers' C-reactive protein (CRP) concentration
timeFrame: At 1 month postpartum
measure: Mothers' C-reactive protein (CRP) concentration
timeFrame: At 6 months postpartum
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
Study officials:
References: