Non-invasive Marker of Infant Food Intake
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Duration of Skin Carotenoid Score Measurements- 4 Month Olds.
研究概览
简要总结
The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.
详细描述
RATIONALE: During infancy, children go from consuming primarily breast milk or formula, to consuming a variety of baby foods and table foods. Doctors, researchers, and community health workers are interested in knowing what foods infants eat, but since many infants have multiple adult caregivers, it can be hard for one caregiver to accurately recall the dietary pattern of the infant. A rapid, non-invasive biomarker of food intake in infants could serve as a useful monitoring tool.
PURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.
OUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-4.5 months old at baseline
- •born at term (>/=37 weeks gestation)
- •within the 5th-95th weight-for-age percentile (inclusive)
- •primary caregiver can speak, read, and understand English
- •infants are exclusively breast- and/or formula-feeding at baseline
- •consenting parent or caregiver must be 18 years old or older
排除标准
- •has a sibling enrolled in the study
- •metabolic, digestive, or malabsorptive disorders
- •known bleeding or clotting disorder
- •requires a special diet
- •exposed to tobacco smoke in the home
- •currently taking any isolated carotenoid supplements
- •using medications or complementary or alternative medications that interfere with dietary fat absorption
- •has a history of endocrine disorders requiring hormone administration.
结局指标
主要结局
Duration of Skin Carotenoid Score Measurements- 4 Month Olds.
时间窗: 1 day each
Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: \>0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements. Range: 35-158 s
Infant Plasma Carotenoid Concentration, 4 Months.
时间窗: 1 day
Infant Plasma Total Carotenoid Concentration, 4 months.
Total Carotenoid Intake, 4 Month Olds
时间窗: 7 days
Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary
Skin Carotenoid Scores in 4 Month Olds.
时间窗: Measurements collected at the visit held when participants were 4 months of age.
Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 14-215
次要结局
- Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.(Measurements conducted at the study visit held at either 6 months of age of 8 months of age.)
- Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.(Measurements conducted at the study visit held at either 6 months of age of 8 months of age.)
- Skin Carotenoid Scores in 6 and 8 Month Olds.(Single day at either 6 months of age of 8 months of age.)
- Skin Carotenoid Scores in 6 and 8 Month Olds(Single day at either 6 months of age of 8 months of age.)
- Daily Total Carotenoid Intake, 6 and 8 Month Olds(7 days prior to the visits held at 6 months of age and at 8 months of age.)
研究者
Nancy Engelmann Moran
Assistant Professor
Baylor College of Medicine