Mechanisms Underlying Individual Variations of Taste and Smell in Obesity (NCT04714892) | Clinical Trial Compass
RecruitingNot Applicable
Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
United States350 participantsStarted 2022-05-11
Plain-language summary
Background:
Changes to the sense of taste or smell can change eating behavior. This may contribute to obesity. Researchers want to see how taste and smell perceptions that affect food choices may differ between people with obesity and without obesity.
Objective:
To understand the role that senses of taste and smell play in food intake.
Eligibility:
Adults ages 18-65 with obesity and without obesity
Design:
Participants will be screened with a medical history and physical exam. They will have a neurological and sensory exam. They will give blood and urine samples. They will be checked for previous SARS-CoV-2 infection. They will complete questionnaires about their eating habits, alcohol use, and smoking history.
Participants will have 2 study visits.
Participants will give stool, urine, blood, hair, nasal, and saliva samples. These samples will be used for gene testing.
Participants will have their weight, height, and hip and waist circumference measured. They will have an imaging scan that measures body composition.
Participants will complete questionnaires about their health, eating habits, and food preferences.
Participants will have taste tests and smell tests. They will have sensory tests to assess their response to stimuli.
Participants will have a dietary assessment. They will complete a food diary and a diet history questionnaire.
Participants will get a meal to eat. Data will be collected about their experience.
Participants will complete a sleep diary and wear a watch to measure their activity....
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Males and females between 18 to 65 years of age. Due to documented knowledge that taste and smell changes with age, we will limit the cohort within this age range.
* BMI between 18.5 and 29.9 kg/m\^2 for healthy controls or between 30 and 39.9 kg/m\^2 for obese subjects at screening
* Fasted plasma glucose levels between 68-126 mg/dl or per Clinical Center ranges, and hemoglobin A1C\<6.5%
* Able to provide his/her own consent
* Able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Because type-2 diabetic subjects have blunted taste responses, subjects with diagnosis of type II diabetes will be excluded.
* Hypoglycemic drug intake.
* Weight change of more than 15 pounds in the 6 months prior to screening
* Positive pregnancy test, currently pregnant or breastfeeding.
* Currently using any of the following medications: steroidal or nonsteroidal antiinflammatory medications, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, or antibiotics.
* Received a diagnosis by a medical professional of morbid obesity, liver or renal disease.
* Individuals with current heavy drinking. Women who drink 4 drinks or more in one occasion an…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measures of taste and smell, and eating behavior
Timeframe: At enrollment
Trial details
NCT IDNCT04714892
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)