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Human Oral Detection of Glucose Olygomers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589353
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Juyun Lim, Oregon State University

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE April 21, 2017
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Oral Detection of Glucose Olygomers
Official Title  ICMJE The Role of Salivary Contents in Taste Perception of Starch and Its Hydrolysis Products
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE 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)
Study Arms  ICMJE 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)
Intervention: Drug: Acarbose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Juyun Lim 541-737-6507 juyun.lim@oregonstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589353
Other Study ID Numbers  ICMJE IRB # 5373
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juyun Lim, Oregon State University
Study Sponsor  ICMJE Oregon State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juyun Lim Oregon State University
PRS Account Oregon State University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP