Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers

Completed

• Conditions: Healthy

• Registration Number: NCT05047588
• Lead Sponsor: Monell Chemical Senses Center

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.

Study Timeline

• Study Start: 2019-08-29
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-17
• Primary Completion: 2021-11-09
• Study Completion: 2022-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diet intake	Through study completion, average 2 and a half years	Two days of dietary intake will be obtained by having mothers report all the foods and beverage eaten during past day using the Automated Self-Administered Recall System (ASA24). Mothers will complete for herself and her child on two separate days. From these data, we will obtain daily energy intake (kcal/d), sugar (g/d; kcal/d) intake
PALS/ALS Liking surveys	Through study completion, average 2 and a half years	Liking of different types of foods will by assessed by Preschool Adapted Liking Survey (PALS) for children \[range -100 (maximal dislike) to 100 (maximal like)\] and the Adult Liking Survey (ALS) for adults \[range -100 (maximal dislike) to 100 (maximal like)\]
Hair Biomarker for added sugar intake	After study completion, 2022	Three cm of each hair sample will undergo stable isotope ratio mass spectrometry that will yield the concentration of carbon-13 relative to carbon-12 (added sugar biomarker, which has been shown to be associated with added sugar intake in older children and adults. Each cm reflects the added sugar intake of one month.
Sweet taste preferences	Through study completion, average 2 and a half years	Level of sucrose most preferred as determined by the Monell forced-choice tracking method \[range of sucrose solutions: 0.09 to 1.05 M\]

Secondary Outcome Measures

Name	Time	Method
Eating Behavior constructs	Through study completion, average 2 and a half years	Mothers will complete the 35-item Adult Eating Behavior Questionnaire to describe her eating behaviors and the 26-item Children's Eating Behavior Questionnaire to describe her child's eating behaviors. Each item is scored from 1 (disagree/never) to 5 (agree/always) and are averaged and categorized into the following eating behavior constructs: enjoyment of food, food responsiveness, satiety responsiveness, emotional overeating; emotional undereating, and food fussiness. Higher numbers reflect more of the behavior.
Anthropometry	Through study completion, average 2 and a half years	We will measure each participant's height (in cm) and weight (in kg). From these two measures, we will combine to calculate BMI (kg/m2) as well as determine the corresponding BMI-for-age percentile in children and BMI in adults.
Waist-to-Hip ratio	Through study completion, average 2 and a half years	We will measure each participant's waist and hip in cm from which the ratio is calculated.

Trial Locations

Locations (1)

Monell Chemical Senses Center; 🇺🇸 Philadelphia, Pennsylvania, United States