Alcohol Drinking
Conditions
Brief summary
The goal of this pilot study is to identify the role of satiety on responses to alcohol drinking using human subject laboratory methods. Satiety will be manipulated over two sessions using a dietary supplement (fiber+green tea) or a calorically matched placebo. Responses to an acute alcohol challenge are measured.
Detailed description
Participants will receive a beverage containing either a dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener for taste + 725mg decaffeinated green tea extract capsule) or a calorically matched placebo supplement (Aspartame sweetener mixed with water + aspartame capsule) counterbalanced at two separate visits. Forty-five minutes after the dietary supplement, a priming drink (calculated to achieve 0.03g/dL Blood Alcohol Concentration; BAC) is administered. Response to alcohol is measured using standardized questionnaires and a cognitive task. Then over a 2-hour period, additional mini-drinks are administered. Responses to standardized questionnaires are collected after each drink.
Interventions
DIETARY_SUPPLEMENTDietary Fiber + Green Tea Extract
10g fiber + 750mg green tea supplement will be administered at experimental arm
OTHERAlcohol
alcohol administered up to a target BAC 0.06g/dL during lab sessions
OTHERAspartame Placebo Supplement
Aspartame sweetener mixed with water + aspartame capsule
Sponsors
Research Society on Alcohol
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
participant will be blinded to the session order in which they receive either the dietary supplements (fiber and green tea) or a placebo.
Intervention model description
within-subjects placebo-controlled design
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21-45 * Meeting NIAAA criteria for current at-risk drinking (i.e., \>7/14 drinks in one week for women/men, with at least one episodes of 4+/5+ drinks in the past 30 days) * Willingness to complete laboratory sessions involving blood draws and alcohol administration * Ability to communicate and read in English * Body mass index (BMI) of 21 - 30 kg/m\^2
Exclusion criteria
* Meets past-year criteria for severe Alcohol Use Disorder (\>7 of 11 symptoms endorsed) or AUDIT score of 20+ * Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder) * Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use * Current use of weight control medications * Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder) * History of suicide attempt, or psychiatric hospitalization in the last 6 months * History of diabetes * Medical conditions or medications for which alcohol is contraindicated * Pregnant, nursing, or trying to become pregnant * Plans to travel during the duration of study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Specific Satiety Score | baseline to 60 minutes | The Alcohol-specific Satiety Questionnaire is a 16-item instrument designed to measure satiety to alcohol's effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 160 with higher values representing greater alcohol-specific satiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score | baseline to 60 minutes | The Subjective Effects of Alcohol Scale (SEAS) (0-70, 10 point scale) is a 14 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol. |
| Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) | baseline to 60 minutes | The Biphasic Alcohol Effect Scale (BAES) is a 14-item instrument designed to measure the stimulant and sedative subjective effects of alcohol. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol. |
| Change in Attention Bias to Alcohol Score | 30 minutes after alcohol administration | The Visual Dot-Probe Paradigm is used to measure attention bias to alcohol. Participants are asked to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an alcohol related image, might be embedded in a matrix of neutral images). Attention biases are inferred from faster response times to detect a alcohol related stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices. Thus, positive times reflect attention bias toward alcohol, whereas negative times reflect attention bias away from alcohol. |
| Change in Alcohol Demand Score | baseline to 60 minutes | The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero. |
| Change in Alcohol Urge Questionnaire Score | baseline to 60 minutes | The Alcohol Urge Questionnaire (AUQ) is an 8 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Strongly agree; 1 to Agree; 7, yielding average scores from 1 to 7 with higher values indicating a greater alcohol craving. |
Countries
United States
Participant flow
Recruitment details
Of the 64 individuals who signed informed consent, 44 participants were randomized to 1 of 2 intervention arms.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who received a placebo supplement (Aspartame sweetener mixed with water + aspartame capsule) and the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants also received a drink containing alcohol (vodka + cranberry mixer) on both sessions. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Primary
Change in Alcohol Specific Satiety Score
The Alcohol-specific Satiety Questionnaire is a 16-item instrument designed to measure satiety to alcohol's effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 160 with higher values representing greater alcohol-specific satiety.
Time frame: baseline to 60 minutes
Population: Participants completing both sessions with pre- and post-treatment data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Alcohol Specific Satiety Score | -0.51 score on a scale | Standard Deviation 5.25 |
| Placebo | Change in Alcohol Specific Satiety Score | 4.85 score on a scale | Standard Deviation 5.45 |
Secondary
Change in Alcohol Demand Score
The Alcohol Purchase Task is a 20-question self-report measure which asks participants about the number of drinks they would purchase and consume based at different monetary costs. Intensity scores reflect the number of drinks that would be purchased when cost is zero.
Time frame: baseline to 60 minutes
Population: Participants completing both sessions with pre- and post-treatment data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Alcohol Demand Score | -0.15 number of drinks | Standard Deviation 1.67 |
| Placebo | Change in Alcohol Demand Score | 0.00 number of drinks | Standard Deviation 1 |
Secondary
Change in Alcohol Urge Questionnaire Score
The Alcohol Urge Questionnaire (AUQ) is an 8 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Strongly agree; 1 to Agree; 7, yielding average scores from 1 to 7 with higher values indicating a greater alcohol craving.
Time frame: baseline to 60 minutes
Population: Participants completing both sessions with pre- and post-treatment data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Alcohol Urge Questionnaire Score | 3.66 score on a scale | Standard Deviation 7.43 |
| Placebo | Change in Alcohol Urge Questionnaire Score | 3.31 score on a scale | Standard Deviation 4.37 |
Secondary
Change in Attention Bias to Alcohol Score
The Visual Dot-Probe Paradigm is used to measure attention bias to alcohol. Participants are asked to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an alcohol related image, might be embedded in a matrix of neutral images). Attention biases are inferred from faster response times to detect a alcohol related stimulus in a matrix of neutral stimuli relative to response time to detect neutral stimuli in neutral matrices. Thus, positive times reflect attention bias toward alcohol, whereas negative times reflect attention bias away from alcohol.
Time frame: 30 minutes after alcohol administration
Population: Participants completing both sessions with pre- and post-treatment data are reported. All available data are reported. Data are missing for one observation due to computer malfunction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Attention Bias to Alcohol Score | -15.5 milliseconds | Standard Deviation 45.3 |
| Placebo | Change in Attention Bias to Alcohol Score | 6.63 milliseconds | Standard Deviation 30.3 |
Secondary
Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score
The Subjective Effects of Alcohol Scale (SEAS) (0-70, 10 point scale) is a 14 item instrument designed to measure the magnitude of alcohol's subjective effects. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol.
Time frame: baseline to 60 minutes
Population: Participants completing both sessions with pre- and post-treatment data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score | 2.59 score on a scale | Standard Deviation 0.98 |
| Placebo | Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score | 2.84 score on a scale | Standard Deviation 0.94 |
Secondary
Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)
The Biphasic Alcohol Effect Scale (BAES) is a 14-item instrument designed to measure the stimulant and sedative subjective effects of alcohol. Ratings are made from Not at all; 0 to Extremely; 10, yielding total scores from 0 to 70 with higher values indicating a greater subjective response to alcohol.
Time frame: baseline to 60 minutes
Population: Participants completing both sessions with pre- and post-treatment data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement | Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) | 0.05 score on a scale | Standard Deviation 1.05 |
| Placebo | Change in Subjective Stimulation (Biphasic Alcohol Effects Scale) | 0.05 score on a scale | Standard Deviation 0.89 |