Mechanisms Underlying Individual Variations of Taste and Smell in Obesity

NCT04714892 | Recruiting

• 2 other identifiers: 10000261000261-AA
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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....

Conditions

Obesity

Keywords

chemosensation; Olfaction; Diet; obese; Perception; Natural History

Outcome Measures

Primary Outcomes (1)

• Measures of taste and smell, and eating behavior

  Compare individuals with obesity to healthy controls in measures of taste and smell and eating behaviors.

  At enrollment

Secondary Outcomes (4)

• Inflammatory markers, exosome and microbiota

  At enrollment

• Gene expression, DNA methylation, taste and smell measures

  At enrollment

• Biological measures, personal factors, taste and smell measures

  At enrollment

• Severity of neuropsychological sysmptoms such as fatigue, anxiety, depression, sleep; perceived stress, pain and QoL

  At enrollment

Study Arms (2)

Healthy control

BMI of 18.5-29.9 kg/m2

Obese

BMI of 30-39.9 kg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Washington DC metropolitan area and vicinity.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Anosmia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Paule V Joseph, C.R.N.P.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada M Saleh

CONTACT

(301) 496-3799; nada.saleh@nih.gov

Paule V Joseph, C.R.N.P.

CONTACT

paule.joseph@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 20, 2021
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data may be available 5 years after the completion of the primary endpoint. Requests can be made by contacting the study PI.
• Access Criteria: Data will be shared through restricted access to NIH-designated data repositories. Data and samples may be shared with investigators and institutions with an FWA or operating under the Declaration of Helsinki (DoH). Such sharing of data will be reported at the time of continuing review. Sharing with investigators without an FWA or not operating under the DoH will be submitted for prospective IRB approval. Submissions to NIH-sponsored or supported databases and repositories will be reported at the time of Continuing Review. Submission to non-NIH-sponsored or supported databases and repositories will be submitted for prospective IRB approval.

Locations

US (1)