Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677321

Collaborator

(none)

475

Enrollment

Location

58.8

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Alcohol use disorder (AUD) is the most common substance use disorder in the world. Long-term AUD can affect a person s sense of taste and smell. This natural history study will compare alcohol drinking behaviors and measures of taste and smell in people with and without AUD.

Objective:

To understand how alcohol use changes the senses of taste and smell.

Eligibility:

People aged 18 to 65 years with or without AUD.

Design:

Participants will be screened. They will have several tests to assess their smell and taste functions. They will answer questions about their eating, alcohol use, and smoking or vaping habits.

Participants will have 2 study visits.

They will give samples of blood, nasal mucous, saliva, stool, and urine.

Their bodies will be measured. They will undergo a type of scan that uses X-rays to measure their body composition.

They will complete taste measurements. They will taste liquids by swishing them in their mouth, without swallowing. Then, they will be asked what they can detect and which flavors they preferred.

They will also complete smell measurements. They will be asked if they can identify strong odors on a metal wand. They will be asked to rate the intensity and pleasantness of odors.

Their brain activity in the frontal regions will be measured while they smell various odors. For this, we will use a brain imaging tool called functional near infrared spectroscopy.

They will have sensory testing. Sensations such as pressure, pinpricks, heat, or vibrations will be applied to their skin. Then, they will be asked what they felt.

They will keep diaries. They will write down what they eat (for 3 days), the alcohol they drink (3 days), and how much they sleep (14 days). They will wear a wristwatch-like device that records their activity for 14 days.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder

Detailed Description

Study Description:

This study involves comparison of taste and smell measures between individuals with and without AUD. However, AUD has also been associated with alterations in taste and smell, these alterations in taste and smell are inherently concerning, regardless of whether they have any bearing on the course of other aspects of AUD. Therefore, in the proposed study we intend to assess the taste and smell differences between individuals with and without AUD. Also, we would explore the extent of taste and smell alteration in individuals with AUD and identify the biological correlates of these alterations in taste and smell.

Objectives:

AUD is a major public health concern in America. Overconsumption of alcohol is a recognized risk factor for the development of future alcohol problems. Public health efforts to modify drinking behaviors have had limited success. Not only does alcohol overuse contribute to AUD, albeit it can lead to changes in gut microbiota, as well as salivary and metabolic hormones that likely result in inflammation. Taste and smell perceptions, which can influence alcohol consumption, may differ between individuals with AUD and those without. Currently, little is known about the biomarkers related to variations in taste and smell systems in individuals with AUD. We plan to perform a series of analysis designed to investigate how individuals' variations in taste and smell perception affect alcohol consumption. We will conduct deep phenotype for taste and smell and collect blood, saliva, and nasal samples to assess the biomarkers.

Findings from this study can be used to provide evidence for future mechanistic studies to identify targets and strategies for countermeasures in preventing or improving AUD and its comorbidities. Moreover, outcomes will foster new lines of investigation for reducing risk of alcohol-related concurrent taste and smell alterations. The proposed research is aligned with the overall mission of the National Institutes of Health to promote health and disease prevention. Lastly, approaches included in this study 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. This is a hypothesis-generating protocol which plays an important role at the initial stages of clinical research. We expect that the findings of the present proposed study would add some clarification to the existing contradictory reports on the chemosensory changes associated with AUD. Most importantly, this protocol is likely to help identify the differential impact of alcohol consumption on chemosensation in individuals with and without AUD.

Endpoints:

Primary Endpoint: The primary dependent measures for this study are taste and olfaction measures.

Secondary Endpoints: Secondary measures include inflammatory markers, genotypes, microbiota, salivary and metabolic hormones, biological measures, and personal factors.

Study Design

Study Type:

Observational

Anticipated Enrollment :

475 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)

Anticipated Study Start Date :

Feb 6, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Participants with AUD Drink regularly (i.e., 2 or more drinks per day for at least 3 days per week in the past 12 months)
Participants without AUD Does not drink regularly (less than 2 drinks per day for at least 3 days per week in the past 12 months)

Outcome Measures

Primary Outcome Measures

Taste and smell measures, alcohol drinking behavior [At enrollment]
Compare individuals with AUD to those without AUD in measures of taste and smell and alcohol drinking behaviors.

Secondary Outcome Measures

Inflammatory markers, genotypes, microbiota, salivary and metabolic hormones, biological measures, and personal factors [At enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

Individuals between 18 to 65 years of age. Although the age range of participants recruited in the NIAAA Natural History protocol is between 18-77 years, due to documented knowledge that taste and smell diminishes with age, we will limit age to this range.
Individuals with a diagnosis of AUD (for the AUD cohort) OR without a diagnosis of AUD (for the non-AUD cohort)
Able to provide their own consent.
Due to the extensive questionnaires (administered in English language only) that participants must complete independently, fluency in the English language is needed. Hence, participants must be able to read and understand English.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

Because type-2 diabetic individuals have blunted taste responses, those with diagnosis of type-2 diabetes will be excluded.
Diagnosis by a medical professional of morbid obesity or BMI > 40, liver, or renal disease. Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric).
Any history of chronic rhinitis, eating disorder (including binge eating), acute or chronic upper respiratory infection, allergic rhinitis, nasal polyps, or daily use of nasal sprays.
Altered cranial nerves associated with taste and olfaction identified by neurological evaluation during physical exam (screening visit).
Hemoglobin A1C level > 6.5%.
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, ferritin < 10 ug/L 18 g/dL
Positive pregnancy test, currently pregnant or breastfeeding.
Hypoglycemic drug intake.
Individual is on a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
Currently using or have used any of the following medications in the 6 months prior to screening: daily use of steroidal anti-inflammatory medication, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, antibiotics.
Daily use of nonsteroidal anti-inflammatory medication within 2 weeks.
Regular use of illicit drugs (e.g., marijuana, cocaine) in the last 30 days
Diagnosis of substance use disorder in the last 12 months.
Regular use of probiotics/ yogurt consumption >= 1 serving per day for the last 30 days.
Current cold/flu symptoms or temporary loss of taste and/or smell (individual may be rescreened when symptoms resolve).
Persistent loss of taste and/or smell due to COVID-19.
NIAAA employees/staff or subordinates/relatives/co-workers of NIAAA employees/staff or study investigators.