AzTrials
AzTrials

HealthySWBIONCT05047588

Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers

An observational study of Healthy, run by Monell Chemical Senses Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 3 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
277 participants
Where
1 siteUnited States
Study dates
29 Aug 2019to 1 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy adults and children

Who may be able to join

  • 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.

Who cannot join

  • Diagnosis of Type 2 Diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Monell Chemical Senses Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Healthy
Keywords
taste, children, dietary intake, biomarker, adult, sugar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: Through study completion, average 2 and a half years

  2. 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

    Measured: Through study completion, average 2 and a half years

  3. 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)]

    Measured: Through study completion, average 2 and a half years

  4. 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.

    Measured: After study completion, 2022

Secondary outcomes (3)

  1. 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.

    Measured: Through study completion, average 2 and a half years

  2. 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.

    Measured: Through study completion, average 2 and a half years

  3. Waist-to-Hip ratio

    We will measure each participant's waist and hip in cm from which the ratio is calculated.

    Measured: Through study completion, average 2 and a half years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start29 Aug 2019
  3. Primary completion9 Nov 2021
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047588
Sponsor's protocol ID
833299
Acronym
SWBIO
Status last verified
Feb 2023
First submitted
13 Aug 2021
Last updated
3 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39978470

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Monell Chemical Senses Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sweet taste preferences (time frame: Through study completion, average 2 and a half years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047588, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.

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