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The COVID-19 pandemic made the recruitment and follow-up of this study impractical.
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The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants | Infants, 4-4.5 months of age at enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of Skin Carotenoid Score Measurements- 4 Month Olds. | 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 | 1 day each |
| Infant Plasma Carotenoid Concentration, 4 Months. | Infant Plasma Total Carotenoid Concentration, 4 months. | 1 day |
| Total Carotenoid Intake, 4 Month Olds | Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary | 7 days |
| Skin Carotenoid Scores in 4 Month Olds. | 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 | Measurements collected at the visit held when participants were 4 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds. | Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: >0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s | Measurements conducted at the study visit held at either 6 months of age of 8 months of age. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited using the CNRC and BCM clinical study recruitment websites and listservs, the CNRC volunteer database, word of mouth, and approved flyers posted on the BCM campus, the Texas Children's Health Plan Center for Women and Children clinics, the Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) pediatric clinics, and the TCH/BCM obstetrics and gynecology clinics. We will also distribute flyers in-person (pending the permission of the clinic) in the waiting rooms of the TCH/BCM pediatrics and Texas Children's Health Plan Clinic and at sites throughout the community.
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| Name | Affiliation | Role |
|---|---|---|
| Nancy E. Moran, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39033693 | Background | Juneja S, Chang J, Nguyen T, Castaneda R, O'Connor TM, Musaad S, Moran NE. The relative validity of nutrition assessment methods for estimating infant carotenoid intake differs by assessment tool, nutrient database, and milk carotenoid adjustment method. Nutr Res. 2024 Aug;128:38-49. doi: 10.1016/j.nutres.2024.06.003. Epub 2024 Jun 13. | |
| 35981784 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants | Infants, 4-4.5 months of age at enrollment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants | Infants, 4-4.5 months of age at enrollment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Skin Carotenoid Score Measurements- 4 Month Olds. | 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 | Posted | Mean | Standard Deviation | seconds | 1 day each |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infants | Infants, 4-4.5 months of age at enrollment | 0 |
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The group sizes for this study were small, participants were recruited from only one geographic location in the US, there is an increase risk of type I error due to multiple testing, only infants with minimal solid food intake were eligible to enroll at 4 months, which may not be representative of the general 4 month old infant population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy E. Moran, PhD | Baylor College of Medicine | 713-798-0520 | nancy.moran@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2022 | Mar 21, 2023 | Prot_SAP_000.pdf |
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blood plasma from infant, breast milk from lactating mother if applicable
| Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds. | Time Required for Heel 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. | Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 40-324 | Single day at either 6 months of age of 8 months of age. |
| Skin Carotenoid Scores in 6 and 8 Month Olds | Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 59-200 | Single day at either 6 months of age of 8 months of age. |
| Daily Total Carotenoid Intake, 6 and 8 Month Olds | Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660 | 7 days prior to the visits held at 6 months of age and at 8 months of age. |
| Moran NE, Chang J, Stroh R, Zaidi Y, Hason N, Musaad S, O'Connor T. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable. J Nutr. 2023 Jan 14;152(12):2966-2977. doi: 10.1093/jn/nxac182. |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass, g | Mean | Standard Deviation | grams |
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| Weight for Age, percentile | Mean | Standard Deviation | percentile |
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| Units | Counts |
|---|
| Participants |
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| Primary | Infant Plasma Carotenoid Concentration, 4 Months. | Infant Plasma Total Carotenoid Concentration, 4 months. | There are fewer blood samples than the total enrolled population due to some samples that could not be collected due to venipuncture difficulty and some families opting out of blood sampling. | Posted | Mean | Standard Deviation | umol/L | 1 day |
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| Primary | Total Carotenoid Intake, 4 Month Olds | Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary | Posted | Mean | Standard Deviation | ug/d | 7 days |
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| Primary | Skin Carotenoid Scores in 4 Month Olds. | 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 | all enrolled participants attending the first visit | Posted | Mean | Standard Deviation | skin carotenoid score units, 0-800 scale | Measurements collected at the visit held when participants were 4 months of age. |
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| Secondary | Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds. | Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: >0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s | Posted | Mean | Standard Deviation | seconds | Measurements conducted at the study visit held at either 6 months of age of 8 months of age. |
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| Secondary | Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds. | Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds. | Posted | Mean | Standard Deviation | seconds | Measurements conducted at the study visit held at either 6 months of age of 8 months of age. |
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| Secondary | Skin Carotenoid Scores in 6 and 8 Month Olds. | Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 40-324 | Posted | Mean | Standard Deviation | score on a scale | Single day at either 6 months of age of 8 months of age. |
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| Secondary | Skin Carotenoid Scores in 6 and 8 Month Olds | Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores. Range: 59-200 | Posted | Mean | Standard Deviation | score on a scale | Single day at either 6 months of age of 8 months of age. |
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| Secondary | Daily Total Carotenoid Intake, 6 and 8 Month Olds | Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660 | Due to loss to follow up, the n for these analyses is fewer than the starting population enrolled for visit 1 (4 months of age) | Posted | Mean | Standard Deviation | ug/d | 7 days prior to the visits held at 6 months of age and at 8 months of age. |
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| 21 |
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