Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners
NCT ID: NCT06387316
Last Updated: 2024-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-26
2025-03-30
Brief Summary
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Detailed Description
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First Lab Visit (Day 1):
Consent and Instruction: Researchers will explain the study procedures, including the use of continuous glucose monitoring (CGM), home-based taste testing and wearing the Fitbit activity tracker. Participants will complete a short questionnaire (screening questionnaire) that elicits demographic, health and activity information. Participants can choose to decline to answer any questions they prefer not to answer. Researchers will determine if participants meet eligibility criteria and participants will then decide if they want to participate. A CGM device will be placed on the participant's arm to monitor glucose levels continuously. Placing the monitor involves putting an egg-shaped plastic container (about the size of a golf ball) on the back of one arm and a button is pushed and this presses the sensor on the arm. It is held on by adhesive. It is like applying a band aid though there is a hair-like flexible fiber that is pressed into the skin (not into a vein). The participant feels little more than mild pressure - far less than a needle stick. Participants will be given individually portioned, labeled sample solutions including a nutritive sweetener, non-nutritive sweetener, a non-sweet control stimulus (salt) and just water along with commercially available no sodium rice cakes (cut to bite-size pieces). Participants will be instructed to place one rice cake sample in their mouth and sip a 5ml oral solution sample and masticate for 15 seconds and expectorate. This will be repeated 3 additional times. With about 15 seconds between samples. This exposure will require about 2 minutes. This will be repeated 4 times a day (before breakfast, before lunch, before dinner and at 8PM) on 8 days. There will be no oral stimulation for 2 days. Participants will be provided with activity recall sheets and instructed to record their sleep patterns, and physical activity for 10 days. This form will only contain an identification code, no personally identifiable information be on the form. Participants will also be asked to wear a Fitbit to monitor activity. This is exactly like wearing a wristwatch.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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No Oral Stimulation
No oral stimulation is provided.
No Oral Stimulation
No oral stimulation
Oral Water Stimulation
Oral stimulation with water.
Oral water stimulation
Oral water stimulation
Oral Salt Stimulation
Oral stimulation with salt.
Oral Salt Stimulation
Oral Salt Stimulation
Oral Sucralose Stimulation
Oral stimulation with sucralose.
Oral Sucralose Stimulation
Oral Sucralose Stimulation
Oral Sucrose stimulation
Oral stimulation with sucrose.
No Oral Stimulation
No oral stimulation
Oral Sucrose stimulation
Oral Sucrose stimulation
Interventions
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No Oral Stimulation
No oral stimulation
Oral water stimulation
Oral water stimulation
Oral Salt Stimulation
Oral Salt Stimulation
Oral Sucralose Stimulation
Oral Sucralose Stimulation
Oral Sucrose stimulation
Oral Sucrose stimulation
Eligibility Criteria
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Inclusion Criteria
* Good health and without known medical conditions, including but not limited to, diabetes, cardiovascular diseases, metabolic disorders, and any other chronic conditions that could significantly affect glycemia.
* No history of major surgeries, organ transplantations, or significant medical interventions that might impact glycemia.
* No medications that could interfere with glucose metabolism or sweet taste perception. Use of vitamins or contraceptives will be permissible if continued for the 12 days of study participation.
* No dietary restrictions or sensitivities that prevent them from tasting or swishing sweeteners and rice cakes provided during the study.
18 Years
70 Years
ALL
Yes
Sponsors
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Purdue University
OTHER
Responsible Party
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Richard Mattes
Distinguished Professor
Principal Investigators
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Richard Mattes, PhD
Role: PRINCIPAL_INVESTIGATOR
Purdue University
Locations
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Purdue University
West Lafayette, Indiana, United States
Countries
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Other Identifiers
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2023-1526
Identifier Type: -
Identifier Source: org_study_id
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