Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT04714892
Eligibility Criteria:
* 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
* 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 and 7 drinks in a week. Men who drink 5 drinks or more in one occasion and more than 14 drinks a week.
* Use of tobacco products or illicit drugs (as determined by urine drug screen and/or history/physical exam) in the last 30 days.
* Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric).
* Any self-reported history of chronic rhinitis, eating disorder (including binge eating), chronic upper respiratory infection, chronic allergic rhinitis, or nasal polyps in the last 6 months of screening, or current daily use of nasal sprays.
* Abnormal complete blood count (CBC): White Blood Cell Count \< 4 or \> 10 K/uL, Red Blood Cell Count \< 4 or \> 7 M/uL, Hemoglobin \< 12 g/dL for females or \< 13 g/dL for males or any clinical signs/symptoms that indicate iron deficiency anemia per clinician s judgment at screening \[National Heart, Lung and Blood Institute (NHLBI) definition (Anemia - Iron-Deficiency Anemia, Diagnosis NHLBI, NIH)\].
* Bariatric surgery within the last 12 months of screening.
* History of cancer (e.g., head and neck cancer) and/or history of cancer treatment (e.g., radiotherapy to the head and neck area or chemotherapy).
* Altered cranial nerves identified by neurological evaluation during physical exam (screening visit).
* Currently experiencing temporary change/loss of taste and/or smell.
* Persistent loss of taste and/or smell due to COVID-19 or other reasons.
* Unable to read and understand English. Since all self-report measures are in English only, participants need to be able to read and understand the English language.
* NIAAA employees/staff or subordinates/relatives/co-workers of NIAAA employees/staff or study investigators.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04714892
Study Brief:
Protocol Section:
NCT04714892