Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-06 @ 2:04 PM
Study NCT ID:
NCT04714892
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Organization:
Study Overview
Official Title:
Mechanisms Underlying Individual Variations of Taste and Smell in Obesity
Status:
RECRUITING
Status Verified Date:
2025-08-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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....
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....
Detailed Description:
Study Description:
This study involves comparison of taste and smell measures between obese and non-obese individuals. 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.
Objectives:
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. Moreover, findings will foster new lines of investigation for reducing risk of diet related conditions and for developing novel behavioral and pharmacological avenues of treatment and prevention. The proposed research is aligned with the overall mission of the National Institutes of Health to promote health and disease prevention. The findings from this study will ultimately lead to the development of personalized interventions for individuals with obesity and concurrent taste and smell alterations. Lastly, approaches included in this proposal are innovative and highly applicable to other complex health phenomena in which biological variations in inflammation and taste and smell perception impact an individual s health.
Endpoints:
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 involves comparison of taste and smell measures between obese and non-obese individuals. 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.
Objectives:
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. Moreover, findings will foster new lines of investigation for reducing risk of diet related conditions and for developing novel behavioral and pharmacological avenues of treatment and prevention. The proposed research is aligned with the overall mission of the National Institutes of Health to promote health and disease prevention. The findings from this study will ultimately lead to the development of personalized interventions for individuals with obesity and concurrent taste and smell alterations. Lastly, approaches included in this proposal are innovative and highly applicable to other complex health phenomena in which biological variations in inflammation and taste and smell perception impact an individual s health.
Endpoints:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000261-AA | None | None | View |