Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Mothers' incremental area under glucose response curves
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study staff will be instructed to assign allocated numbers to participants in sequential order as they are enrolled. Once the assignment (1, 2 or 3) is revealed to the study team, study information per that assignment will be explained to the participant. It is essential for the research team to know the allocation in order to provide the correct intervention materials and relevant counseling. Thus, the design is open-label, with only outcome assessors blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≤ 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.
排除标准
- •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.
研究组 & 干预措施
Control (Group 1)
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.
干预措施: Control Intervention (Behavioral)
NNS Restriction in Lactation (Group 2)
Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
干预措施: NNS Restriction Intervention (Behavioral)
NNS Restriction in Lactation (Group 2)
Participants in this arm will maintain their usual NNS consumption during pregnancy but will receive an intervention to restrict NNS intake during lactation.
干预措施: Control Intervention (Behavioral)
NNS Restriction in Pregnancy and Lactation (Group 3)
Participants in this arm will receive an intervention to restrict NNS intake both during pregnancy and lactation.
干预措施: NNS Restriction Intervention (Behavioral)
结局指标
主要结局
Mothers' incremental area under glucose response curves
时间窗: At 28 weeks gestation
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy on maternal glucose tolerance by assessing the incremental area under the 120 minute glucose response curves.
Infants' adiposity
时间窗: At 6 months of age
Determine the impact of restricting usual consumption of non-nutritive sweeteners (NNS) during pregnancy and/or lactation influences infants' adiposity, which is known to be predictive of potential future obesity risk by assess infants' fat mass percent.
次要结局
- Infants' adiposity(At 1 month of age)
- Mothers' 60 minute glucose concentration(At 28 weeks gestation)
- Mothers' fasting blood glucose concentration(At 6 months postpartum)
- Infants' gestational age(At birth)
- Infants' birthweight(At birth)
- Mothers' assessment of insulin resistance(At 28 weeks gestation)
- Mothers' 120 minute glucose concentration(At 28 weeks gestation)
- Infants' age-sex specific percentile(At 6 months of age)
- Mothers' insulin sensitivity index(At 28 weeks gestation)
- Infants' birthweight based on gestational age(At birth)
- Mothers' energy intake(At 6 months postpartum)
- Mothers' fasting blood glucose concentration(At 28 weeks gestation)
- Mothers' fasting blood glucose concentration(At 1 month postpartum)
- Infants' age-sex specific percentile(At 1 month of age)
- Mothers' energy intake(At 28 weeks gestation)
- Mothers' energy intake(At 1 month postpartum)
研究者
Allison Sylvetsky (Meni)
Associate Professor
George Washington University