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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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/confirmed genetic fetal abnormalities or suspected or known congenital birth defects. - History of prior gastric bypass surgery.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Study staff will be instructed to assign allocated numbers to participants in sequential order as they are enrolled. Once the assignment (1, 2 or 3) is revealed to the study team, study information per that assignment will be explained to the participant. It is essential for the research team to know the allocation in order to provide the correct intervention materials and relevant counseling. Thus, the design is open-label, with only outcome assessors blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control (Group 1) 		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.
  • Behavioral: Control Intervention
    Counsel about best practices for home safety and babyproofing. Provide a detailed booklet to take home, which will provide information about home safety and baby proofing. Educate about common causes of accidental infant and young child injuries or death. Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.
Active Comparator
NNS Restriction in Lactation (Group 2) 		Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
  • Behavioral: NNS Restriction Intervention
    Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health. Provide 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. Emphasize 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. Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages. Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS
  • Behavioral: Control Intervention
    Counsel about best practices for home safety and babyproofing. Provide a detailed booklet to take home, which will provide information about home safety and baby proofing. Educate about common causes of accidental infant and young child injuries or death. Automated text messages will also be sent to mothers once per week with reminders about home safety, infant safety, and baby proofing.
Active Comparator
NNS Restriction in Pregnancy and Lactation (Group 3) 		Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.
  • Behavioral: NNS Restriction Intervention
    Discuss current scientific literature surrounding NNS consumption, obesity, and chronic disease and the emerging evidence that consumption in pregnancy/lactation may have unfavorable effects on infants' adiposity and health. Provide 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. Emphasize 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. Bi-weekly shipments of unsweetened beverages of participant's choice to replace usual consumption of NNS containing beverages. Automated text messages will also be sent to mothers once per week with reminders that they should avoid NNS

Recruiting Locations

The George Washington University
Washington D.C. 4140963, District of Columbia 4138106 20037
Contact:
Allison C Sylvetsky, PhD
202-994-5602
asylvets@gwu.edu

More Details

Status
Recruiting
Sponsor
George Washington University

Study Contact

Allison C Sylvetsky, PhD
202-994-5602
asylvets@gwu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.