NCT03996395: BIBS

Baylor Infant Biomarker of Nutrition Study

Terminated Results posted Last updated 15 November 2024

What this trial tests

trial in Healthy Infant Nutrition in 21 participants. Terminated before completion.

Timeline

8 April 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Baylor College of Medicine
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	21
Start date	8 April 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Conditions studied

• Healthy Infant Nutrition — all drugs for Healthy Infant Nutrition →

Sponsor

Baylor College of Medicine

Who can join

Adults 4 Months to 9 Months, any sex, with Healthy Infant Nutrition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Duration of Skin Carotenoid Score Measurements- 4 Month Olds. Primary · 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

Group	Value	95% CI
Finger	84	± 31
Heel	71	± 23

Infant Plasma Carotenoid Concentration, 4 Months. Primary · 1 day

Infant Plasma Total Carotenoid Concentration, 4 months.

Group	Value	95% CI
4 Month Olds	0.821	± 0.412

Total Carotenoid Intake, 4 Month Olds Primary · 7 days

Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary

Group	Value	95% CI
4 Month Olds	225	± 104

Skin Carotenoid Scores in 4 Month Olds. Primary · 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

Group	Value	95% CI
Finger	92.4	± 56.6
Heel	92.4	± 51.4

Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds. Secondary · 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

Group	Value	95% CI
6 Month Olds	63	± 32
8 Month Olds	62	± 17

Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds. Secondary · 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.

Group	Value	95% CI
6 Month Olds	62	± 17
8 Month Olds	87	± 32

Skin Carotenoid Scores in 6 and 8 Month Olds. Secondary · 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

Group	Value	95% CI
6 Month Olds	108.9	± 40.5
8 Month Olds	161.0	± 89.1

Skin Carotenoid Scores in 6 and 8 Month Olds Secondary · 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

Group	Value	95% CI
6 Month Olds	118	± 43.6
8 Month Olds	197	± 128.4

Daily Total Carotenoid Intake, 6 and 8 Month Olds Secondary · 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

Group	Value	95% CI
6 Month Olds	1330	± 1620
8 Month Olds	3650	± 2700

Sponsor's own description

The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable.
   Moran NE, Chang J, Stroh R, Zaidi Y, et al · · 2023 · cited 9× · PMID 35981784 · DOI 10.1093/jn/nxac182