SWBIO: Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers

Sponsor
Monell Chemical Senses Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05047588
Collaborator
(none)
300
1
36.1
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Stable Isotope Biomarker for Added Sugar Intake and Sweet Taste Phenotypes in Mother-child Dyads
    Actual Study Start Date :
    Aug 29, 2019
    Actual Primary Completion Date :
    Nov 9, 2021
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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

    3. 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)]

    4. 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.

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monell Chemical Senses Center Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Monell Chemical Senses Center

    Investigators

    • Study Director: Julie A Mennella, PhD, Monell Chemical Senses Center
    • Principal Investigator: Alissa D Smethers, RD PhD, Monell Chemical Senses Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Monell Chemical Senses Center
    ClinicalTrials.gov Identifier:
    NCT05047588
    Other Study ID Numbers:
    • 833299
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Monell Chemical Senses Center

    Study Results

    No Results Posted as of Mar 4, 2022