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临床试验/NCT06387316
NCT06387316Unknown不适用

Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners

Purdue University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Blood glucose concentration

研究概览

简要总结

This study will focus on changes in blood sugar in response to tasting different types of sweeteners using continuous glucose monitoring (CGM) technology.

详细描述

Participants will be recruited through posting of advertisements about the study. Flyers will be posted on and off campus. Individuals interested in the study will contact the researchers and an initial appointment will be scheduled.

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

solutions are coded

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults aged between 18 to 70 years old will be eligible to participate.
  • •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.

排除标准

  • 未提供

研究组 & 干预措施

Oral Sucrose stimulation

Other

Oral stimulation with sucrose.

干预措施: No Oral Stimulation (Other)

Oral Sucrose stimulation

Other

Oral stimulation with sucrose.

干预措施: Oral Sucrose stimulation (Other)

Oral Sucralose Stimulation

Other

Oral stimulation with sucralose.

干预措施: Oral Sucralose Stimulation (Other)

No Oral Stimulation

Other

No oral stimulation is provided.

干预措施: No Oral Stimulation (Other)

Oral Water Stimulation

Other

Oral stimulation with water.

干预措施: Oral water stimulation (Other)

Oral Salt Stimulation

Other

Oral stimulation with salt.

干预措施: Oral Salt Stimulation (Other)

结局指标

主要结局

Blood glucose concentration

时间窗: 10 days

blood glucose concentration measured by continuous glucose monitoring

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Mattes

Distinguished Professor

Purdue University

研究点 (1)

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