Human Oral Detection of Glucose Olygomers

NCT02589353 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB # 5373
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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 will investigate the variation in salivary contents across individuals and its role in taste perception of glucose polymers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Drug: Acarbose

Interventions

Acarbose DRUG

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)

Acarbose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (1)

Department of Food Science and Technology

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Interventions

Acarbose

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Juyun Lim

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 28, 2015
• Study Start: April 21, 2017
• Primary Completion: December 16, 2022
• Study Completion: February 16, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

US (1)