Clinical trial NCT05047588: Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers
Official title: Stable Isotope Biomarker for Added Sugar Intake and Sweet Taste Phenotypes in Mother-child Dyads
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: taste
children
dietary intake
biomarker
adult
sugar
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 277
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and children

Brief summary: The goals of this cross-sectional study on a racially diverse group of children (3-10y) and their mothers are to determine whether the relationship between sweet taste phenotypes differed among mother-daughter and mother-son dyads and to determine the predictive value of a hair biomarker (delta13C). Given the widespread overconsumption of added sugars, and the associated burden of disease, improving surveillance measures and developing strategies to reduce added sugar intake, especially among the youngest members of society, are public health priorities.

Detailed description: This is a single-site cross-sectional study designed to investigate the relationship of sweet taste phenotypes among mother-child dyads and assess the predictive value of a hair biomarker for sweet taste phenotypes. For each participant, we will collect 2-day 24-hour dietary recalls to determine added sugar intake; directly assess the level of sweet taste most preferred; measure liking/disliking of sweet tasting foods and beverages; collect anthropometric measures; and collect at least 3 cm of hair for biomarker analyses. Mothers will also complete a variety of questionnaires on parenting and child behavior.

Eligibility criteria: Inclusion Criteria:

* Hair that is greater than or equal to 3 cm in length
* Child is between the ages of 3 and 10 years and adult is between the ages of 18 and 70
* Access to electronic device including Smartphone, iPad, tablet, laptop, or desktop computer for participation in remote study visits.

Exclusion Criteria:

* Diagnosis of Type 2 Diabetes

Primary outcomes:
measure: Sweet taste preferences
timeFrame: Through study completion, average 2 and a half years
measure: Diet intake
timeFrame: Through study completion, average 2 and a half years
measure: PALS/ALS Liking surveys
timeFrame: Through study completion, average 2 and a half years
measure: Hair Biomarker for added sugar intake
timeFrame: After study completion, 2022
Secondary outcomes:
measure: Anthropometry
timeFrame: Through study completion, average 2 and a half years
measure: Eating Behavior constructs
timeFrame: Through study completion, average 2 and a half years
measure: Waist-to-Hip ratio
timeFrame: Through study completion, average 2 and a half years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A Mennella, PhD
role: STUDY_DIRECTOR
affiliation: Monell Chemical Senses Center
name: Alissa D Smethers, RD PhD
role: PRINCIPAL_INVESTIGATOR
References: