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Recruiting NCT06548828

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

No phase Interventional Gestational Diabetes Mellitus in Pregnancy Glucose Intolerance During Pregnancy Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNS Restriction Intervention, Control Intervention.
Who it may be relevant to
Registry conditions: Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Infants' adiposity [Time frame: At 6 months of age]
  • Mothers' incremental area under glucose response curves [Time frame: At 28 weeks gestation]
Secondary outcome measures (12)
  • Infants' adiposity [Time frame: At 1 month of age]
  • Mothers' fasting blood glucose concentration [Time frame: At 28 weeks gestation]
  • Mothers' fasting blood glucose concentration [Time frame: At 1 month postpartum]
  • Mothers' fasting blood glucose concentration [Time frame: At 6 months postpartum]
  • Mothers' 60 minute glucose concentration [Time frame: At 28 weeks gestation]
  • Mothers' 120 minute glucose concentration [Time frame: At 28 weeks gestation]
  • Infants' gestational age [Time frame: At birth]
  • Infants' birthweight [Time frame: At birth]
  • Infants' birthweight based on gestational age [Time frame: At birth]
  • Infants' age-sex specific percentile [Time frame: At 1 month of age]
  • Infants' age-sex specific percentile [Time frame: At 6 months of age]
  • Mothers' insulin sensitivity index [Time frame: At 28 weeks gestation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The George Washington University — Washington D.C.

Identifiers

NCT: NCT06548828 · SweetPea · R01HD107427

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗