Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- 1-hour Acesulfame-potassium Concentrations in Breast Milk
研究概览
简要总结
This project aims to measure the widely consumed low-calorie sweeteners (LCS) sucralose and acesulfame-potassium, in maternal breast milk and plasma at pre-specified timepoints over 72 hours and in a single sample of infants' plasma. Sucralose and acesulfame-potassium concentrations will be measured using liquid chromatography-mass spectrometry (LC-MS). The data generated will inform the design of larger, longer-term, prospective studies needed to investigate clinically-relevant consequences of early life LCS exposure in humans.
详细描述
Low-calorie sweetener (LCS) consumption is highly prevalent among lactating women, yet the current understanding of LCS effects on diet, weight, and health is extremely limited, especially when exposure begins early in life. This project aims to measure the widely consumed LCSs, sucralose and acesulfame-potassium, in maternal breast milk and plasma, at pre-specified, time-points over the course of 72 hours, and in a single sample of infants' plasma (analyzed using a population pharmacokinetics approach).
Mothers will attend an enrollment visit, which will take place virtually and will schedule an in-person visit to take place at Children's National Hospital approximately one week later. During the enrollment visit, informed consent will be obtained and demographic, anthropometric, and dietary data will be collected. During the week prior to their scheduled in-person study visit, mothers will be instructed to continue their usual dietary habits and to complete an online, photo-assisted, 7-day food record.
Mothers will be instructed to arrive fasted for the in-person visit, which will last for approximately 13 hours. Following ingestion of a diet beverage containing sucralose and ace-K, mothers will remain at Children's National for supervised serial sample collection at pre-determined time points over 12 hours, and will provide additional samples on three subsequent consecutive days (72 hours). Mothers will be instructed to continue to complete the online, photo-assisted, food record for the three days following the in-person study visit (until 72 hours following diet beverage consumption).
A plasma sample will be collected from each infant via heel-stick at one of the following pre-specified time intervals following the mother's ingestion of the diet beverage: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, 9-14 hours, and 22-36 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •mother gave birth within the past 6 months
- •mother ≥18 years of age
- •exclusively breastfeeding
- •reports consumption of diet, low-calorie sweetener-containing beverages ≥ 1 time per week.
- •infants' corrected age >= 4 weeks
排除标准
- •known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
- •active nutritional disorder known to cause malabsorption
结局指标
主要结局
1-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 1 hour post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Sucralose Concentration in Breast Milk
时间窗: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
1-hour Sucralose Concentration in Breast Milk
时间窗: 1 hour post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2-hour Sucralose Concentrations in Breast Milk
时间窗: 2 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3-hour Sucralose Concentrations in Breast Milk
时间窗: 3 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4-hour Sucralose Concentrations in Breast Milk
时间窗: 4 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6-hour Sucralose Concentrations in Breast Milk
时间窗: 6 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8-hour Sucralose Concentrations in Breast Milk
时间窗: 8 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12-hour Sucralose Concentrations in Breast Milk
时间窗: 12 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24-hour Sucralose Concentrations in Breast Milk
时间窗: 24 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Breast Milk
时间窗: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
2-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 2 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 3 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 4 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 6 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 8 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 12 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24-hour Acesulfame-potassium Concentrations in Breast Milk
时间窗: 24 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Sucralose Concentration in Maternal Plasma
时间窗: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
30-min Sucralose Concentration in Maternal Plasma
时间窗: 30 minutes post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1 Hour Sucralose Concentration in Maternal Plasma
时间窗: 1 hour post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1.5 Hour Sucralose Concentration in Maternal Plasma
时间窗: 1.5 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2 Hour Sucralose Concentration in Maternal Plasma
时间窗: 2 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3 Hour Sucralose Concentration in Maternal Plasma
时间窗: 3 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4 Hour Sucralose Concentration in Maternal Plasma
时间窗: 4 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6 Hour Sucralose Concentration in Maternal Plasma
时间窗: 6 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8 Hour Sucralose Concentration in Maternal Plasma
时间窗: 8 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12 Hour Sucralose Concentration in Maternal Plasma
时间窗: 12 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24 Hour Sucralose Concentration in Maternal Plasma
时间窗: 24 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
48 Hour Sucralose Concentration in Maternal Plasma
时间窗: 48 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
72 Hour Sucralose Concentration in Maternal Plasma
时间窗: 72 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
30 Min Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 30 minutes post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 1 hour post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 1.5 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 2 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 3 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 4 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 6 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 8 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 12 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 24 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
48 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 48 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
72 Hour Acesulfame-potassium Concentrations in Maternal Plasma
时间窗: 72 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Sucralose Concentrations in Infant Plasma
时间窗: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Mean concentration of sucralose in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Acesulfame-potassium Concentrations in Infant Plasma
时间窗: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Mean concentration of acesulfame-potassium in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
次要结局
未报告次要终点