DevelopmentNCT02909764
Shifting Salty Taste Preferences in Children
A study testing Low Sodium Group in people with Development, run by Monell Chemical Senses Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Development
- What is being tested?
- Low Sodium Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy
- Willingness to consume no other cereals during intervention
Who cannot join
- Allergies and/or taking medication that affects taste
Trial locations and contacts
1 site in 1 country.
United States1 site
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Development
- Being tested
- Low Sodium Group
- Keywords
- Salty taste, Psychophysics, Genetics, Diet, Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium GroupOther
Breakfast Cereal
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Children will receive regularly salted cereal to consume 4 times per week over a 2-month period. |
| Low Sodium Group | Experimental | Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. Receives: Other: Low Sodium Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most Preferred Level of Salt Taste
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.
Measured: Baseline (time 0) and after 8-week intervention
Relative Preference for Regular vs Low Sodium Cereal
The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal
Measured: At baseline and after 8-week intervention
Secondary outcomes (4)
Salt Taste Detection Thresholds
Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure
Measured: Baseline and after 8-week intervention
Most Preferred Level of Sucrose
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.
Measured: At baseline and after 8-week intervention
Intake of Cereal During Intervention Period
Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.
Measured: 28 days
Blood Pressure
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie A Mennella, PhD, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909764
- Sponsor's protocol ID
- 823281
- Status last verified
- Sep 2019
- First submitted
- 1 Sep 2016
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bobowski N, Mennella JA. Repeated Exposure to Low-Sodium Cereal Affects Acceptance but Does not Shift Taste Preferences or Detection Thresholds of Children in a Randomized Clinical Trial. J Nutr. 2019 May 1;149(5):870-876. doi: 10.1093/jn/nxz014.
PubMed 31006818
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salty Taste: Assessing a Strategy to Reduce Children's Preference
- ClinicalTrials.gov ID
- NCT02909764
- Acronym / sponsor ID
- 823281
- Conditions
- Development
- Keywords
- Salty taste, Psychophysics, Genetics, Diet, Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Children will receive regularly salted cereal to consume 4 times per week over a 2-month period. |
| Low Sodium Group | Experimental | Other: Low Sodium GroupIntervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy
- Willingness to consume no other cereals during intervention
Key exclusion criteria (1 listed)
- Allergies and/or taking medication that affects taste
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Sodium GroupBreakfast Cereal | Other | Low Sodium Group |
Primary outcome
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.
Relative Preference for Regular vs Low Sodium Cereal
Time frame: At baseline and after 8-week intervention
The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal
4 secondary outcomes
Salt Taste Detection Thresholds
Time frame: Baseline and after 8-week intervention
Most Preferred Level of Sucrose
Time frame: At baseline and after 8-week intervention
Intake of Cereal During Intervention Period
Time frame: 28 days
Blood Pressure
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31006818Bobowski N, Mennella JA. Repeated Exposure to Low-Sodium Cereal Affects Acceptance but Does not Shift Taste Preferences or Detection Thresholds of Children in a Randomized Clinical Trial. J Nutr. 2019 May 1;149(5):870-876. doi: 10.1093/jn/nxz014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Mennella, PhD principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Sodium Group in people with Development, 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 2 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 30 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Most Preferred Level of Salt Taste (time frame: Baseline (time 0) and after 8-week intervention). The study lists 2 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 NCT02909764, 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 30 Sep 2019.