Impairment of Oral PerceptionAFS-adultNCT02335021
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
A study testing Sucralose, Sucrose and Sucralose + maltodextrin in people with Impairment of Oral Perception and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and… Read more about this study
- Who is it for?
- Ages 23 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impairment of Oral Perception, Insulin Resistance
- What is being tested?
- Sucralose, Sucrose and Sucralose + maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 24 Apr 2019
- Phase
- Interventional
- 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 23 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Fluent in English
- Right handed
Who cannot join
- History of oral nerve damage,
- presence of known taste or smell disorder,
- food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
- history of CNS disease,
- diabetes,
- history of DSM-IV major psychiatric disorder,
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- including alcohol and substance abuse,
- chronic use of medication that may affect taste,
- conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies,
- recent smoking history),
- aberrant stimulus ratings,
- contra-indication for fMRI,
- uncomfortable swallowing in supine position,
- discomfort or anxiety associated with insertion an intravenous catheter,
- regular artificial sweetener use.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.
Read the detailed description
We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.
- Conditions
- Impairment of Oral Perception, Insulin Resistance
- Being tested
- Sucralose, Sucrose, Sucralose + maltodextrin, Sucralose + Sucrose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucraloseDietary supplement
2 packets per 12 fl oz
SucroseDietary supplement
equisweet to sucralose
Sucralose + maltodextrinDietary supplement
sucralose plus equicaloric (to sucrose) maltodextrin
Sucralose + SucroseDietary supplement
half the amount of sucralose plus equicaloric sucrose
| Study group | Role | What they receive |
|---|---|---|
| Sucralose | Experimental | Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucralose. Receives: Dietary Supplement: Sucralose |
| Sucrose | Experimental | Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucrose. Receives: Dietary Supplement: Sucrose |
| Sucralose + maltodextrin | Experimental | Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + maltodextrin . Receives: Dietary Supplement: Sucralose + maltodextrin |
| Sucralose + Sucrose | Experimental | Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + sucrose. Receives: Dietary Supplement: Sucralose + Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratings of taste sensitivity
general labeled magnitude scale ratings of taste intensity
Measured: up to one week after intervention
Secondary outcomes (2)
Ad libitum food intake
amount of Mac\&Cheese consumed
Measured: up to one week after intervention
brain response to taste stimuli
BOLD response as measured by fMRI
Measured: up to one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study start1 Jan 2015
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impairment of Oral PerceptionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana M Small, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335021
- Sponsor's protocol ID
- 0405026766-2
- Acronym
- AFS-adult
- Status last verified
- Sep 2019
- First submitted
- 24 Oct 2014
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be publicly shared at publication of manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
- ClinicalTrials.gov ID
- NCT02335021
- Acronym / sponsor ID
- AFS-adult / 0405026766-2
- Conditions
- Impairment of Oral Perception, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 9 Jan 2015 (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 purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.
Detailed description
We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sucralose | Experimental | Dietary Supplement: SucraloseParticipants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucralose. |
| Sucrose | Experimental | Dietary Supplement: SucroseParticipants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucrose. |
| Sucralose + maltodextrin | Experimental | Dietary Supplement: Sucralose + maltodextrinParticipants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + maltodextrin . |
| Sucralose + Sucrose | Experimental | Dietary Supplement: Sucralose + SucroseParticipants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + sucrose. |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Fluent in English
- Right handed
Key exclusion criteria (15 listed)
- History of oral nerve damage,
- presence of known taste or smell disorder,
- food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
- history of CNS disease,
- diabetes,
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 |
|---|---|---|
| Sucralose2 packets per 12 fl oz | Dietary supplement | Sucralose |
| Sucroseequisweet to sucralose | Dietary supplement | Sucrose |
| Sucralose + maltodextrinsucralose plus equicaloric (to sucrose) maltodextrin | Dietary supplement | Sucralose + maltodextrin |
| Sucralose + Sucrosehalf the amount of sucralose plus equicaloric sucrose | Dietary supplement | Sucralose + Sucrose |
Primary outcome
Ratings of taste sensitivity
Time frame: up to one week after intervention
general labeled magnitude scale ratings of taste intensity
2 secondary outcomes
Ad libitum food intake
Time frame: up to one week after intervention
brain response to taste stimuli
Time frame: up to one week after intervention
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 26 Sep 2019.
- Individual participant dataSharing planned: Yes. De-identified data will be publicly shared at publication of manuscript.
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.
Dana M Small principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucralose, Sucrose and Sucralose + maltodextrin in people with Impairment of Oral Perception and Insulin Resistance, run by Yale University 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 15 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 26 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?
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?
Ratings of taste sensitivity (time frame: up to one week after intervention). 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 26 Sep 2019.