Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04714892|
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : July 28, 2022
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.
To understand the role that senses of taste and smell play in food intake.
Adults ages 18-65 with obesity and without obesity
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.
|Condition or disease|
This study involves comparison of taste and smell measures between individuals with and without obesity Taste and smell perceptions will be assessed in terms of their influence in food intake and food choices. We hypothesize that obesity negatively affects taste and smell perception thus affecting eating behavior.
Obesity is a major public health concern in America. An unhealthy diet is a recognized risk factor for the development of obesity. Public health efforts to modify eating behaviors have had limited success. Not only does an unhealthy diet contribute to obesity, but it can also lead to changes in gut microbiota that likely result in inflammation and changes in transcriptomic activity. Taste and smell perceptions, which can influence food choices and food consumption, may differ between obese and non-obese individuals. Currently, little is known about the underlying mechanisms causing variations in taste and smell systems in individuals with obesity, which limits the interventions currently available to address this critical issue. Findings from this study can be used to design more effective interventions for the prevention and treatment of obesity, to identify targets and strategies for countermeasures to prevent or improve obesity and its comorbidities, and to suggest ways to enhance dietary interventions.
Primary Endpoint: The primary dependent measures for this study are taste and olfaction measures.
Secondary Endpoints: Secondary measures include inflammatory markers, exosomes, microbiota, gene expression, DNA methylation, biological measures and personal factors.
This study will take place at the NIH Clinical Center.
The study is expected to be completed in 60 months from opening of enrollment to study completion of data analysis.
This study involves one screening visit and 2 study visits. The screening visit will last approximately 4-5 hours. Visits 1 and 2 will take approximately 4-6 hours each to complete.
|Study Type :||Observational|
|Estimated Enrollment :||248 participants|
|Official Title:||Mechanisms Underlying Individual Variations of Taste and Smell in Obesity|
|Actual Study Start Date :||May 11, 2022|
|Estimated Primary Completion Date :||December 30, 2024|
|Estimated Study Completion Date :||December 30, 2024|
BMI of 18.5-29.9 kg/m2
BMI of 30-39.9 kg/m2
- Measures of taste and smell, and eating behavior [ Time Frame: At enrollment ]Compare individuals with obesity to healthy controls in measures of taste and smell and eating behaviors.
- Inflammatory markers, exosome and microbiota [ Time Frame: At enrollment ]Compare individuals with obesity to healthy controls in measures of inflammation (cytokines and chemokines) in circulating blood, and neuronally-derived exosomes from plasma, and in the oral and nasal microbiome composition and its metabolites.
- Gene expression, DNA methylation, taste and smell measures [ Time Frame: At enrollment ]Compare individuals with obesity to healthy controls on transcriptomic and epigenomic profiles in monocytes, based on gene expression (RNA sequencing) and whole genome DNA methylation, to identify associated variations in taste and smell perception.
- Biological measures, personal factors, taste and smell measures [ Time Frame: At enrollment ]Examine how biological measures of inflammation and genomic profiles relate to taste and smell variations based on personal factors (i.e., race, age, and sex) and other factors (i.e., diet) within the obese group
- Severity of neuropsychological sysmptoms such as fatigue, anxiety, depression, sleep; perceived stress, pain and QoL [ Time Frame: At enrollment ]Evaluate symptoms clusters with alterations in taste and smell and identify phenotypic symptoms characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714892
|Contact: Shavonne N Pocock||(301) firstname.lastname@example.org|
|Contact: Paule V Joseph, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Paule V Joseph, C.R.N.P.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|