Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NCT04714892
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 350
- US sites recruiting
- 1
- Study start
- May 11, 2022
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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....
Conditions: Obesity
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
National Institutes of Health Clinical Center
Bethesda, MD 20892
Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov
Study contacts (from the official record)
- Nada M Saleh · (301) 496-3799 · nada.saleh@nih.gov
- Paule V Joseph, C.R.N.P. · paule.joseph@nih.gov
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