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

George Washington University (GW)

Status: Enrolling

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

Treatments: Behavioral: NNS Restriction Intervention; Behavioral: Control Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06548828

R01HD107427 (U.S. NIH Grant/Contract)

SweetPea

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 3 patient groups

Control (Group 1)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Intervention

NNS Restriction in Lactation (Group 2)

Active Comparator group

Description:

Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.

Treatment:

Behavioral: Control Intervention

Behavioral: NNS Restriction Intervention

NNS Restriction in Pregnancy and Lactation (Group 3)

Active Comparator group

Description:

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

Treatment:

Behavioral: NNS Restriction Intervention