Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers

Healthy Clinical Trial

— SWBIO  

Official title:

Stable Isotope Biomarker for Added Sugar Intake and Sweet Taste Phenotypes in Mother-child Dyads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047588
• Other study ID #: 833299
• Status: Completed
• Start date: August 29, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2023
• Source: Monell Chemical Senses Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: September 1, 2022
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Monell Chemical Senses Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sweet taste preferences	Level of sucrose most preferred as determined by the Monell forced-choice tracking method [range of sucrose solutions: 0.09 to 1.05 M]	Through study completion, average 2 and a half years
Primary	Diet intake	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	Through study completion, average 2 and a half years
Primary	PALS/ALS Liking surveys	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)]	Through study completion, average 2 and a half years
Primary	Hair Biomarker for added sugar intake	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.	After study completion, 2022
Secondary	Anthropometry	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.	Through study completion, average 2 and a half years
Secondary	Eating Behavior constructs	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.	Through study completion, average 2 and a half years
Secondary	Waist-to-Hip ratio	We will measure each participant's waist and hip in cm from which the ratio is calculated.	Through study completion, average 2 and a half years