RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-19
Study Completion:2029-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06548828

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant
  2. * ≤ 16 weeks' gestation
  3. * Singleton pregnancy
  4. * Report frequent NNS beverage consumption (≥ 7 servings/week)
  5. * 18-45 years of age
  6. * Able to read English at a 5th grade level; and
  7. * Intend to breastfeed for at least the first 6 months of life.
  8. * For infants: The mother must be enrolled and provide assent for the infant to participate.
  1. * Physician diagnosis of a major medical illness (e.g. cancer, cardiovascular disease, chronic hypertension);
  2. * Pre-existing diabetes or GDM in a previous pregnancy;
  3. * Physical or mental concerns preventing study participation;
  4. * Medication (e.g., metformin; GLP-1 agomists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;
  5. * Tobacco or drug use during pregnancy;
  6. * Alcohol consumption (\>1 drink per week) during pregnancy;
  7. * 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;
  8. * Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-19
Study Completion Date2029-02

Study Record Updates

Study Start Date2024-08-19
Study Completion Date2029-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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