Healthy VolunteersPhase 4NCT02589353
Human Oral Detection of Glucose Olygomers
A Phase 4 study testing Acarbose in people with Healthy Volunteers, run by Oregon State University at 1 site in United States.
Trial summary
Although salivary contents play a major role in the early stage of food digestion process, their role in taste perception of glucose polymers is essentially unknown. It is hypothesized that the differences in salivary contents, more specifically salivary amylase concentration and activity, influence taste perception… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2017to 16 Feb 2023
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- self-reported healthy adults between the ages of 18-60 who are fluent in English.
Who cannot join
- adults 61 years old and above
- smokers
- pregnant women
- taking any prescription pain/ insulin medication
- has a history of taste or smell loss or other oral disorders (e.g., burning mouth syndrome)
- has current oral lesions, canker sores, or piercings
- has a history of food allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Technology
Corvallis, Oregon, 97331
About this study
Official title: The Role of Salivary Contents in Taste Perception of Starch and Its Hydrolysis Products
Although salivary contents play a major role in the early stage of food digestion process, their role in taste perception of glucose polymers is essentially unknown. It is hypothesized that the differences in salivary contents, more specifically salivary amylase concentration and activity, influence taste perception of glucose polymers and ultimately eating behavior, which is related to risks in various diseases. The current project will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers.
- Conditions
- Healthy Volunteers
- Being tested
- Acarbose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Acarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Experimental | Acarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions) Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of glucose polymers in the presence of acarbose
There is only one outcome measure, that is the detection of glucose polymers. Subjects will be asked to discriminate a target sample (glucose polymers). Three samples will be applied using cotton swabs on the subjects' tongue (one at a time): 2 blanks (water + acarbose) and 1 target stimuli (glucose polymer solution + acarbose). Subjects will be asked to identify the target sample. The number of subjects who correctly identify the target stimuli will be counted and will be statistically analyzed to determine whether glucose polymer can be detected without the confounding effect of salivary alpha amylase hydrolysis.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start21 Apr 2017
- Primary completion16 Dec 2022
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juyun Lim, Oregon State University
- Investigators
- Juyun Lim, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589353
- Sponsor's protocol ID
- IRB # 5373
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2015
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Salivary Contents in Taste Perception of Starch and Its Hydrolysis Products
- ClinicalTrials.gov ID
- NCT02589353
- Acronym / sponsor ID
- IRB # 5373
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 28 Oct 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.
Although salivary contents play a major role in the early stage of food digestion process, their role in taste perception of glucose polymers is essentially unknown. It is hypothesized that the differences in salivary contents, more specifically salivary amylase concentration and activity, influence taste perception of glucose polymers and ultimately eating behavior, which is related to risks in various diseases. The current project will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Experimental | Drug: AcarboseAcarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- self-reported healthy adults between the ages of 18-60 who are fluent in English.
Key exclusion criteria (7 listed)
- adults 61 years old and above
- smokers
- pregnant women
- taking any prescription pain/ insulin medication
- has a history of taste or smell loss or other oral disorders (e.g., burning mouth syndrome)
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 |
|---|---|---|
| AcarboseAcarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions) | Drug | Acarbose |
Primary outcome
Detection of glucose polymers in the presence of acarbose
Time frame: up to 5 years
There is only one outcome measure, that is the detection of glucose polymers. Subjects will be asked to discriminate a target sample (glucose polymers). Three samples will be applied using cotton swabs on the subjects' tongue (one at a time): 2 blanks (water + acarbose) and 1 target stimuli (glucose polymer solution + acarbose). Subjects will be asked to identify the target sample. The number of subjects who correctly identify the target stimuli will be counted and will be statistically analyzed to determine whether glucose polymer can be detected without the confounding effect of salivary alpha amylase hydrolysis.
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 21 Feb 2023.
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Screening Protocol
Pain
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.
Juyun Lim principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose in people with Healthy Volunteers, run by Oregon State 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 1 inclusion and 7 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 21 Feb 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Detection of glucose polymers in the presence of acarbose (time frame: up to 5 years). 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 21 Feb 2023.