DevelopmentTNNSNCT02646956
Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
An observational study of Development, run by Monell Chemical Senses Center.
Trial summary
The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive. Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Development
- What is being tested?
- sweeteners
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2015
- 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 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy children and adults living in the Philadelphia area
Who may be able to join
- Healthy
Who cannot join
- Allergies and taking medication that affected taste
About this study
The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive.
Read the detailed description
This is an observational 3-day study of children between the ages of 7 and 14 and their mothers. A variety of psychophysical methods determined liking for each of the sweeteners and saliva samples were obtained for genotyping of taste receptor genes. Anthropometric and dietary intake measures were also collected.
- Conditions
- Development
- Being tested
- sweeteners
- Keywords
- Sweet Taste, Psychophysics, Genetics, Diet, Age, Nonnutritive Sweetener
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweetenersOther
Participants tasted a variety of nutritive and nonnutritive sweeteners
| Study group | Role | What they receive |
|---|---|---|
| Age Group-Children | Children between ages of 7 and 14 Receives: Other: sweeteners | |
| Age Group-Adults | Healthy adults who are the parent of the children Receives: Other: sweeteners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liking for the taste of sweeteners measured via the 3-point facial hedonic scale.
Measured: Through study completion, an average of 6 months.
Liking for the taste of sweeteners measured via the 5-point facial hedonic scale
Measured: Through study completion, an average of 6 months.
Liking for the taste of sweeteners measured via the Monell forced-choice, paired-comparison tracking procedure.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (3)
Genotyping of taste receptor genes via saliva donation
Genotyping will be completed to measure associations between individual taste receptor genotypes and liking of sweeteners.
Measured: Through study completion, an average of 6 months
BMI calculated from body weight and height measures
BMI will be calculated to examine associations between this measure and liking for sweeteners.
Measured: Through study completion, an average of 6 months
One day dietary intake collected via the Automated Self-Administered 24-hour dietary recall (ASA24).
Dietary recall will be completed to examine associations between added sugar intake and liking for sweeteners.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 82 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
- NCT02646956
- Sponsor's protocol ID
- NIH DC011287
- Acronym
- TNNS
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Preferences for Nutritive and Non Nutritive Sweeteners Among Children and Adults
- ClinicalTrials.gov ID
- NCT02646956
- Acronym / sponsor ID
- TNNS / NIH DC011287
- Conditions
- Development
- Keywords
- Sweet Taste, Psychophysics, Genetics, Diet, Age, Nonnutritive Sweetener
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to determine whether there are age-, diet- and genetically-related differences in the perception of sweeteners, both nutritive and non-nutritive.
Detailed description
This is an observational 3-day study of children between the ages of 7 and 14 and their mothers. A variety of psychophysical methods determined liking for each of the sweeteners and saliva samples were obtained for genotyping of taste receptor genes. Anthropometric and dietary intake measures were also collected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age Group-Children | – | Other: sweetenersChildren between ages of 7 and 14 |
| Age Group-Adults | – | Other: sweetenersHealthy adults who are the parent of the children |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy children and adults living in the Philadelphia area
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Allergies and taking medication that affected 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 |
|---|---|---|
| sweetenersParticipants tasted a variety of nutritive and nonnutritive sweeteners | Other | Age Group-Adults, Age Group-Children |
Primary outcome
Liking for the taste of sweeteners measured via the 3-point facial hedonic scale.
Time frame: Through study completion, an average of 6 months.
Liking for the taste of sweeteners measured via the 5-point facial hedonic scale
Time frame: Through study completion, an average of 6 months.
Liking for the taste of sweeteners measured via the Monell forced-choice, paired-comparison tracking procedure.
Time frame: Through study completion, an average of 6 months.
3 secondary outcomes
Genotyping of taste receptor genes via saliva donation
Time frame: Through study completion, an average of 6 months
BMI calculated from body weight and height measures
Time frame: Through study completion, an average of 6 months
One day dietary intake collected via the Automated Self-Administered 24-hour dietary recall (ASA24).
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Development, run by Monell Chemical Senses Center.
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 1 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 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Liking for the taste of sweeteners measured via the 3-point facial hedonic scale. (time frame: Through study completion, an average of 6 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2016.