NCT05047588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

August 13, 2021

Last Update Submit

February 1, 2023

Conditions

Healthy

Keywords

tastechildrendietary intakebiomarkeradultsugar

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Anthropometry

    Through study completion, average 2 and a half years

  • Eating Behavior constructs

    Through study completion, average 2 and a half years

  • Waist-to-Hip ratio

    Through study completion, average 2 and a half years

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults and children

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis of Type 2 Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Smethers AD, Fisher JO, Carney EM, Coffman DL, Mennella JA. Carbon stable isotope values in hair are associated with added sugar intake in adults but not young children: a cross-sectional study. Am J Clin Nutr. 2025 Apr;121(4):900-909. doi: 10.1016/j.ajcnut.2025.02.013. Epub 2025 Feb 18.

    PMID: 39978470DERIVED

Study Officials

  • Julie A Mennella, PhD

    Monell Chemical Senses Center

    STUDY DIRECTOR

  • Alissa D Smethers, RD PhD

    Monell Chemical Senses Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 17, 2021

Study Start

August 29, 2019

Primary Completion

November 9, 2021

Study Completion

September 1, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations

US(1)