RecruitingPhase not listed

Mechanisms Underlying Individual Variations of Taste and Smell in Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Urine samples, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will give blood and urine samples."
  • "They will complete questionnaires about their eating habits, alcohol use, and smoking history."
  • "Participants will have 2 study visits."
  • "Participants will complete questionnaires about their health, eating habits, and food preferences."
  • "They will complete a food diary and a diet history questionnaire."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how taste and smell affect eating and food choices. It compares adults ages 18–65 with obesity and without obesity. Participants will have two study visits with taste and smell tests, health checks, and sample collection.

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....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–65 years old.
  • Have a body mass index (BMI), a measure of weight compared with height, of 18.5–29.9 or 30–39.9.
  • Have fasting blood sugar of 68–126 mg/dL, or within the study clinic's range.
  • Have an A1C below 6.5%. This blood test measures average blood sugar.
  • Be able to give your own consent and answer all 6 questions correctly on a study consent quiz.

Who can't join

  • Have type 2 diabetes or take medicine that lowers blood sugar.
  • Have gained or lost more than 15 pounds in the past 6 months, or had weight-loss surgery in the past 12 months.
  • Be pregnant, have a positive pregnancy test, or be breastfeeding.
  • Take certain medicines, including anti-inflammatory drugs, GLP-1 drugs, seizure medicines, antidepressants, steroids, or antibiotics.
  • Have diagnosed severe obesity, liver or kidney disease, an uncontrolled illness, certain abnormal blood counts, or a history of cancer or cancer treatment.
  • Have current or lasting taste or smell loss, certain nerve changes, or recent ongoing nose problems, upper airway infections, or eating disorders. Daily nasal spray use also rules you out.
  • Meet the study's limits for heavy drinking, or have used tobacco or illegal drugs in the past 30 days.
  • Be unable to read and understand English, or have a listed work or family connection to NIAAA staff or the study researchers.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD