NCT04714892 Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
| NCT ID | NCT04714892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-05-11 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2022-05-11 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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....
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 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 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.
Contact & Investigator
Paule V Joseph, C.R.N.P.
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT04714892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04714892 currently recruiting?
Yes, NCT04714892 is actively recruiting participants. Contact the research team at nada.saleh@nih.gov for enrollment information.
Where is the NCT04714892 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04714892 clinical trial?
NCT04714892 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Paule V Joseph, C.R.N.P. at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 350 participants.
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