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Completed

NCT Number: NCT05047588

Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers

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.

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Key information

Conditions

Healthy

Age range

3 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sweet taste preferences

    Time frame: 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]

  2. Diet intake

    Time frame: 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

  3. PALS/ALS Liking surveys

    Time frame: 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)]

  4. Hair Biomarker for added sugar intake

    Time frame: 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.

Secondary outcomes

  1. Anthropometry

    Time frame: 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.

  2. Eating Behavior constructs

    Time frame: 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.

  3. Waist-to-Hip ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Monell Chemical Senses Center

Other

Registry information

Official study title

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

Acronym: SWBIO

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 17, 2021
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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