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Идёт набор NCT06548828

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

Без фазы С лечением Gestational Diabetes Mellitus in Pregnancy Glucose Intolerance During Pregnancy Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NNS Restriction Intervention, Control Intervention.
Кому может быть актуально
Состояния в реестре: Gestational Diabetes Mellitus in Pregnancy, Glucose Intolerance During Pregnancy, Non-nutritive Sweeteners Consumption in Pregnancy and/or Lactation. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The George Washington University — Washington D.C.

Идентификаторы

NCT: NCT06548828 · SweetPea · R01HD107427

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗