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Salivary Interactions With Chemosensations

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ClinicalTrials.gov Identifier: NCT03883880
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cordelia Running, PhD, Purdue University

Brief Summary:
A counterbalanced, crossover design will be used to evaluate whether exposure to flavors vs. a control over time alters the perception of the flavor by changing an individual's salivary protein profile. Participants will complete 3 acute tasting protocols (baseline, after intervention 1, after intervention 2). The interventions will be with the flavor (epigallocatechin gallate, linolenic acid, capsaicin) or a control, in counterbalanced order, and will involve swishing and swallowing a solution of that sample 5 times per day for two weeks. Each of these flavors will be a separate sub-study.

Condition or disease Intervention/treatment Phase
Diet, Food Choice, Taste Other: Epigallocatechin gallate Other: Epigallocatechin gallate control Other: Linoleic acid Other: Linoleic acid control Other: Capsaicin solution Other: Capsaicin control Not Applicable

Detailed Description:

This study is designed to test the relationship between salivary proteins, flavor sensation, and flavor exposure. For this study, we will test the bitterness/astringency of epigallocatechin gallate (EGCG, a polyphenol), the oleogustus (fatty acid taste) of linolenic acid, and the spiciness of capsaicin in conjunction with the concentration of specific salivary proteins (initially: salivary proline rich proteins for EGCG intervention, lipocalin-1 for the other two, but other proteins may be identified in the post-hoc analysis of the salivary proteome). We will test whether higher expression of these specific salivary proteins correlates with lower intensity of these flavors. We will further attempt to confirm the role of these salivary proteins using food-sourced functional analogs for these proteins. We would expect the food-sourced protein to have the same effect on flavor as the salivary protein if our hypotheses about salivary proteins' influence on flavor are correct. Finally, we will also use denatured versions of the food-sourced proteins to again confirm that effects are due to the function of these proteins binding the flavor.

Additionally, we will repeatedly expose individuals to the flavors by having them rinse and swallow solutions of the flavor compounds multiple times per day for two weeks. We will then re-evaluate the sensory ratings and salivary protein profiles. Two weeks of rinsing and swallowing a control solution will be used as a control during this intervention (for each of the flavors of interest).

To collect saliva and establish bitterness/astringency perception, we will use an acute tasting protocol. Participants will rinse with water, then taste and swallow, then taste and expectorate a solution of the flavor of interest. Saliva will be frozen for later proteomic analysis. Next participants will taste solutions of: flavor, flavor with food analog, the flavor with denatured food analog, water, water with the food analog, and water with denatured food analog. The participants will rank these solutions in order from least intense to most intense for the flavor quality of interest (bitterness/astringency for EGCG). After this, participants will taste all 6 samples again, and rate each individually for the intensity of the bitterness/astringency. After a short wait, this tasting and intensity rating will be repeated. All tastings will be done in counterbalanced order, and solutions will be labeled with randomized 3-digit codes.

This acute tasting protocol will be done: at baseline, after 2 weeks on one intervention (repeated tasting of flavor or control), after 2 weeks on the other intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Salivary Interactions With Chemosensations
Actual Study Start Date : January 5, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Epigallocatechin gallate
Epigallocatechin gallate solutions will be provided to participants to rinse with daily for two weeks. A control solution will be provided for two weeks as well. Order will be counterbalanced across participants and groups.
Other: Epigallocatechin gallate
Colored solution prepared with epigallocatechin gallate to be consumed daily for two weeks during the epigallocatechin gallate intervention.

Other: Epigallocatechin gallate control
Colored control solution to be consumed daily for two weeks during the epigallocatechin gallate intervention.

Experimental: Linoleic acid
Linoleic acid emulsion will be provided to participants to rinse with daily for two weeks. A control solution will be provided for two weeks as well. Order will be counterbalanced across participants and groups.
Other: Linoleic acid
Colored emulsion prepared with linoleic acid to be consumed daily for two weeks during the linoleic acid intervention.

Other: Linoleic acid control
Colored control solution to be consumed daily for two weeks during the linoleic acid intervention.

Experimental: Capsaicin
Capsaicin solutions will be provided to participants to rinse with daily for two weeks. A control solution will be provided for two weeks as well. Order will be counterbalanced across participants and groups.
Other: Capsaicin solution
Colored solution prepared with capsaicin to be consumed daily for two weeks during the capsaicin intervention.

Other: Capsaicin control
Colored control solution to be consumed daily for two weeks during the capsaicin intervention.




Primary Outcome Measures :
  1. Salivary proteins [ Time Frame: 9 months per sub-study (intervention type) ]
    Subjects saliva will be collected at baseline, after the flavor intervention, and after control intervention (two weeks each, order counterbalanced) for each type of intervention (epigallocatechin gallate, linoleic acid, capsaicin). The proteomic composition of the saliva samples will be established, and used to evaluate relationships with other outcome measures.

  2. Flavor intensity ratings [ Time Frame: 9 months per sub-study (intervention type) ]
    Flavor intensities for the flavor of interest (bitterness/astringency, oleogustus, and spiciness) will be collected at baseline, after the flavor intervention, and after control intervention (two weeks each, order counterbalanced) for each type of intervention (epigallocatechin gallate, linoleic acid, capsaicin). Subjects will rate (in duplicate) the intensity of flavor from the following solutions: flavor in water, flavor in water with food-sourced salivary protein analog, flavor in water with denatured food-sourced salivary protein analog, water, water with food-sourced salivary protein analog , water with denatured food-sourced salivary protein analog. These ratings will be evaluated in context of the timeline of the exposure as well as the salivary proteome.

  3. Flavor rankings [ Time Frame: 9 months per sub-study (intervention type) ]
    Flavor rankings for the flavor of interest (bitterness/astringency, oleogustus, and spiciness) will be collected at baseline, after the flavor intervention, and after control intervention (two weeks each, order counterbalanced) for each type of intervention (epigallocatechin gallate, linoleic acid, capsaicin). Subjects will rank the following solutions from most to least intense: Flavor in water, flavor in water with food-sourced salivary protein analog, flavor in water with denatured food-sourced salivary protein analog, water, water with food-sourced salivary protein analog , water with denatured food-sourced salivary protein analog. These ranking data will be used an another method to gather information on what solutions are most intense to the subject, as the intensity ratings may have complications due to order effects during tastings. These rankings will also be evaluated in context of the timeline of the exposure as well as the salivary proteome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to maintain current diet throughout intervention
  • Agree to inform us if medication use changes during study.
  • Willing and able to taste and consume samples, as well as take pictures to document use of the flavor during intervention.

Exclusion Criteria:

  • Known issues with salivation, taste, or smell
  • Taking medications other than birth control
  • User of tobacco products or electronic cigarettes within the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883880


Contacts
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Contact: Cordelia Running, PhD 765-494-2282 crunning@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Cordelia Running, PhD    765-494-2282    runninglab@purdue.edu   
Principal Investigator: Cordelia Running, PhD         
Sponsors and Collaborators
Purdue University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Cordelia Running, PhD Purdue University

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Responsible Party: Cordelia Running, PhD, Assistant Prof. Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT03883880     History of Changes
Other Study ID Numbers: 082-011
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cordelia Running, PhD, Purdue University:
diet
food choice
taste
Additional relevant MeSH terms:
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Epigallocatechin gallate
Capsaicin
Pharmaceutical Solutions
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents