RECRUITING

Mechanisms Underlying Individual Variations of Taste and Smell in Obesity

Conditions

Obesity chemosensation Olfaction Diet obese Perception Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Mechanisms Underlying Individual Variations of Taste and Smell in Obesity

Quick Facts

Study Start:2022-05-11

Study Completion:2024-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04714892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Khushbu Agarwal, Ph.D.

CONTACT

(301) 385-0799

khushbu.agarwal@nih.gov

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

CONTACT

paule.joseph@nih.gov

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Paule V Joseph, C.R.N.P., PRINCIPAL_INVESTIGATOR, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-11

Study Completion Date2024-12-30

Study Record Updates

Study Start Date2022-05-11

Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

chemosensation
Olfaction
Diet
obese
Perception
Natural History

Additional Relevant MeSH Terms

Obesity