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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)

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

Condition
Gestational Diabetes Mellitus in Pregnancy
Intervention / Treatment

-

Contacts and Locations

Washington

The George Washington University, Washington, District of Columbia, United States, 20037

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Physician diagnosis of a major medical illness (e.g. cancer, cardiovascular disease, chronic hypertension);
  • * Pre-existing diabetes or GDM in a previous pregnancy;
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

George Washington University,

Study Record Dates

2029-02