- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05047588
Added Sugar Intake, Sweet Taste Phenotypes and Biomarkers (SWBIO)
February 1, 2023 updated by: Monell Chemical Senses Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
277
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Monell Chemical Senses Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults and children
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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]
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Through study completion, average 2 and a half years
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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
|
Through study completion, average 2 and a half years
|
|
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)]
|
Through study completion, average 2 and a half years
|
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Hair Biomarker for added sugar intake
Time Frame: After study completion, 2022
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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.
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After study completion, 2022
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, average 2 and a half years
|
|
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.
|
Through study completion, average 2 and a half years
|
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Waist-to-Hip ratio
Time Frame: Through study completion, average 2 and a half years
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Julie A Mennella, PhD, Monell Chemical Senses Center
- Principal Investigator: Alissa D Smethers, RD PhD, Monell Chemical Senses Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2019
Primary Completion (Actual)
November 9, 2021
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
August 13, 2021
First Submitted That Met QC Criteria
September 13, 2021
First Posted (Actual)
September 17, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2023
Last Update Submitted That Met QC Criteria
February 1, 2023
Last Verified
February 1, 2023
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.