Human Oral Detection of Glucose Olygomers

Sponsor

Oregon State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02589353

Collaborator

(none)

300

Enrollment

Location

Arm

82.3

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 of glucose polymers and ultimately eating behavior, which is related to risks in various diseases. The current project is designed to investigate 2 aims. Aim 1 will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers. Aim 2 will focus on the role of salivary contents in food liking and disliking.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Acarbose	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Role of Salivary Contents in Taste Perception of Starch and Its Hydrolysis Products

Actual Study Start Date :

Apr 21, 2017

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acarbose 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)	Drug: Acarbose 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)

Arm

Intervention/Treatment

Experimental: Acarbose

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)

Drug: Acarbose

Outcome Measures

Primary Outcome Measures

Detection of glucose polymers in the presence of acarbose [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

self-reported healthy adults between the ages of 18-60 who are fluent in English.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Food Science and Technology	Corvallis	Oregon	United States	97331

Sponsors and Collaborators

Oregon State University

Investigators

Principal Investigator: Juyun Lim, Oregon State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Juyun Lim, Associate Professor, Oregon State University

ClinicalTrials.gov Identifier:

NCT02589353

Other Study ID Numbers:

IRB # 5373

First Posted:

Oct 28, 2015

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Acarbose

Study Results

No Results Posted as of Apr 20, 2022