Healthy Infant Nutrition
Conditions
Keywords
infant, biomarker, fruit, vegetable, complementary feeding, nutrition, reflectance spectroscopy
Brief summary
The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.
Detailed description
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.
Interventions
None listed
Sponsors
Baylor College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Months to 9 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Skin Carotenoid Score Measurements- 4 Month Olds. | 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. | 1 day | Infant Plasma Total Carotenoid Concentration, 4 months. |
| Total Carotenoid Intake, 4 Month Olds | 7 days | Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary |
| Skin Carotenoid Scores in 4 Month Olds. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Units: Seconds Scale: \>0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s |
| 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. | Total Carotenoid Intake per Day (average) Units: micrograms Scale: \>0 micrograms Range: 100 - 7660 |
| 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. | Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds. |
| 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. 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 |
| 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 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infants Infants, 4-4.5 months of age at enrollment | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Study halted due to COVID-19 pandemic. | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Infants |
|---|---|
| Age, Continuous | 4.14 months STANDARD_DEVIATION 0.11 |
| Body Mass, g | 6890 grams STANDARD_DEVIATION 824 |
| Race/Ethnicity, Customized Black/African-American | 3 Participants |
| Race/Ethnicity, Customized Hispanic White | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 10 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight for Age, percentile | 52.8 percentile STANDARD_DEVIATION 29.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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
Time frame: 1 day each
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Duration of Skin Carotenoid Score Measurements- 4 Month Olds. | 84 seconds | Standard Deviation 31 |
| Heel | Duration of Skin Carotenoid Score Measurements- 4 Month Olds. | 71 seconds | Standard Deviation 23 |
Primary
Infant Plasma Carotenoid Concentration, 4 Months.
Infant Plasma Total Carotenoid Concentration, 4 months.
Time frame: 1 day
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Infant Plasma Carotenoid Concentration, 4 Months. | 0.821 umol/L | Standard Deviation 0.412 |
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
Time frame: Measurements collected at the visit held when participants were 4 months of age.
Population: all enrolled participants attending the first visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Skin Carotenoid Scores in 4 Month Olds. | 92.4 skin carotenoid score units, 0-800 scale | Standard Deviation 56.6 |
| Heel | Skin Carotenoid Scores in 4 Month Olds. | 92.4 skin carotenoid score units, 0-800 scale | Standard Deviation 51.4 |
Primary
Total Carotenoid Intake, 4 Month Olds
Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Total Carotenoid Intake, 4 Month Olds | 225 ug/d | Standard Deviation 104 |
Secondary
Daily Total Carotenoid Intake, 6 and 8 Month Olds
Total Carotenoid Intake per Day (average) Units: micrograms Scale: \>0 micrograms Range: 100 - 7660
Time frame: 7 days prior to the visits held at 6 months of age and at 8 months of age.
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Daily Total Carotenoid Intake, 6 and 8 Month Olds | 1330 ug/d | Standard Deviation 1620 |
| Heel | Daily Total Carotenoid Intake, 6 and 8 Month Olds | 3650 ug/d | Standard Deviation 2700 |
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
Time frame: Single day at either 6 months of age of 8 months of age.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Skin Carotenoid Scores in 6 and 8 Month Olds | 118 score on a scale | Standard Deviation 43.6 |
| Heel | Skin Carotenoid Scores in 6 and 8 Month Olds | 197 score on a scale | Standard Deviation 128.4 |
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
Time frame: Single day at either 6 months of age of 8 months of age.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Skin Carotenoid Scores in 6 and 8 Month Olds. | 108.9 score on a scale | Standard Deviation 40.5 |
| Heel | Skin Carotenoid Scores in 6 and 8 Month Olds. | 161.0 score on a scale | Standard Deviation 89.1 |
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
Time frame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds. | 63 seconds | Standard Deviation 32 |
| Heel | Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds. | 62 seconds | Standard Deviation 17 |
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.
Time frame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finger | Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds. | 62 seconds | Standard Deviation 17 |
| Heel | Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds. | 87 seconds | Standard Deviation 32 |