Human Oral Detection of Glucose Olygomers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Acarbose

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97331
      • Department of Food Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 5 years

Collaborators and Investigators

• Sponsor: Oregon State University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: IRB # 5373

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No