- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909764
Shifting Salty Taste Preferences in Children
September 6, 2019 updated by: Monell Chemical Senses Center
Salty Taste: Assessing a Strategy to Reduce Children's Preference
The goals of the proposed research are to determine whether repeated exposure to a low sodium food will result in reduced preference for salt in that food among children; and to determine whether such reductions in preference are related to dietary intake of salt, taste receptor genotype, and anthropometric and physiological measures.
Study Overview
Detailed Description
This is a within- and between-subjects randomized controlled trial on children consuming either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated exposure to the low sodium cereal is effective for reducing preference for salt in that food.
Children will be genotyped for markers related to taste, dietary intake will be recorded, and anthropometric and physiological measures will be collected at baseline.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Monell Chemical Senses Center
-
-
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
7 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- Willingness to consume no other cereals during intervention
Exclusion Criteria:
- Allergies and/or taking medication that affects taste
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
|
|
Experimental: Low Sodium Group
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
|
Breakfast Cereal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Most Preferred Level of Salt Taste
Time Frame: Baseline (time 0) and after 8-week intervention
|
Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) .
The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations.
Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better.
Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration.
This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively.
The entire task was repeated a, with stimulus pairs presented in reverse order.
The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.
|
Baseline (time 0) and after 8-week intervention
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Relative Preference for Regular vs Low Sodium Cereal
Time Frame: At baseline and after 8-week intervention
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The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal
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At baseline and after 8-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salt Taste Detection Thresholds
Time Frame: Baseline and after 8-week intervention
|
Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure
|
Baseline and after 8-week intervention
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Most Preferred Level of Sucrose
Time Frame: At baseline and after 8-week intervention
|
Children were presented with pairs of sucrose solutions of varying concentrations (0.09, 0.18, 0.35, 0.70, 1.05 M).
The first pair presented were from the middle range of concentrations.
Children tasted each sample and then pointed to the sample they liked better.
Each subsequent pair of samples presented contained the concentration selected by the child paired with an adjacent stimulus concentration.
This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively.
The entire task was repeated after a 3-minute break, with stimulus pairs presented in reverse order.
The geometric mean of the two concentrations chosen in the first and second series was calculated to determine the most preferred levels of sucrose.
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At baseline and after 8-week intervention
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Intake of Cereal During Intervention Period
Time Frame: 28 days
|
Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.
|
28 days
|
Blood Pressure
Time Frame: Baseline
|
Blood pressure (mmHg) was measured by using an automatic blood pressure machine with pediatric cuff.
Blood pressure will be measured at baseline (time 0).
There were no a priori hypothesis but were collected as baseline characteristic to ensure no differences between the groups.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 1, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 21, 2016
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 823281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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