Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes

NCT06548828 | Recruiting DMC

• 2 other identifiers: SweetPeaR01HD107427
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Intolerance During Pregnancy; Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation; Gestational Diabetes Mellitus in Pregnancy

Keywords

Non-nutritive sweeteners (NNS); Pregnancy; Lactation; Infant fat mass; Gestational diabetes (GDM); Glucose tolerance; PeaPod

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Infants' adiposity

  At 1 month of age

• Mothers' fasting blood glucose concentration

  At 28 weeks gestation

• Mothers' fasting blood glucose concentration

  At 1 month postpartum

• Mothers' fasting blood glucose concentration

  At 6 months postpartum

• Mothers' 60 minute glucose concentration

  At 28 weeks gestation

Other Outcomes (9)

• Infants' gut microbiome composition

  At 1 month of age

• Infants' gut microbiome composition

  At 6 months of age

• Mothers' gestational weight gain

  At delivery

Study Arms (3)

Control (Group 1)

ACTIVE COMPARATOR

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

NNS Restriction in Lactation (Group 2)

ACTIVE COMPARATOR

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; Behavioral: Control Intervention

NNS Restriction in Pregnancy and Lactation (Group 3)

ACTIVE COMPARATOR

Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.

Behavioral: NNS Restriction Intervention

Interventions

NNS Restriction Intervention BEHAVIORAL

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

NNS Restriction in Lactation (Group 2); NNS Restriction in Pregnancy and Lactation (Group 3)

Control Intervention BEHAVIORAL

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.

Control (Group 1); NNS Restriction in Lactation (Group 2)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• ≤ 16 weeks gestation
• Singleton pregnancy
• Report frequent NNS beverage consumption (≥ 7 servings/week)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead
• Children's Hospital Los Angeles: collaborator
• Children's National Research Institute: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Allison C Sylvetsky, PhD

CONTACT

202-994-5602; asylvets@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: August 12, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)