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| Name | Class |
|---|---|
| Research Society on Alcohol | OTHER |
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dietary supplement, then placebo | Experimental | Participants receive a dietary supplement at the first study session (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule), and then the next study session they receive the placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions. |
|
| placebo, then dietary supplement | Experimental | Participants receive a placebo supplement at the first study session (Aspartame sweetener mixed with water + aspartame capsule), then the next session they receive the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Fiber + Green Tea Extract | Dietary Supplement | 10g fiber + 750mg green tea supplement will be administered at experimental arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimikaye Courtney, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Of the 64 individuals who signed informed consent, 44 participants were randomized to 1 of 2 intervention arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Supplement, Then Placebo | Participants receive a dietary supplement at the first study session (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule), and then the next study session they receive the placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions. Dietary Fiber + Green Tea Extract: 10g fiber + 750mg green tea supplement will be administered at experimental arm Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions Aspartame Placebo Supplement: Aspartame sweetener mixed with water + aspartame capsule |
| FG001 | Placebo, Then Dietary Supplement | Participants receive a placebo supplement at the first study session (Aspartame sweetener mixed with water + aspartame capsule), then the next session they receive the dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener + 725mg decaffeinated green tea extract capsule). Participants will also receive a drink containing alcohol (vodka + cranberry mixer) on both sessions. Dietary Fiber + Green Tea Extract: 10g fiber + 750mg green tea supplement will be administered at experimental arm Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions Aspartame Placebo Supplement: Aspartame sweetener mixed with water + aspartame capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Session (6 Hours) |
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| Washout (2 Days) |
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| Second Intervention Session (6 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants completing both sessions with pre- and post-treatment data are reported. | Posted | Mean | Standard Deviation | score on a scale | baseline to 60 minutes |
|
Adverse Events were not assessed prior to randomization. Adverse Events were monitored during each session (up to 6 hours). Additionally, an end of session questionnaire gave participants an opportunity to report any adverse events following each session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietary Supplement | Participants who received a dietary supplement during the study (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. Dietary Fiber + Green Tea Extract: 10g fiber + 750mg green tea supplement administered at experimental arm Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bremmer, PhD | University of North Carolina at Chapel Hill | 301-827-0566 | mbremmer@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2024 | Nov 13, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2024 | Aug 14, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D013662 | Tea |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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within-subjects placebo-controlled design
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participant will be blinded to the session order in which they receive either the dietary supplements (fiber and green tea) or a placebo.
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| Alcohol | Other | alcohol administered up to a target BAC 0.06g/dL during lab sessions |
|
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| Aspartame Placebo Supplement | Other | Aspartame sweetener mixed with water + aspartame capsule |
|
|
| baseline to 60 minutes |
| 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. | baseline to 60 minutes |
| 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. | 30 minutes after alcohol administration |
| 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. | baseline to 60 minutes |
| 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. | baseline to 60 minutes |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Participants who received a placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants also received a drink containing alcohol (vodka + cranberry mixer) on both sessions. Aspartame Placebo Supplement: Aspartame sweetener mixed with water + aspartame capsule Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions |
|
|
| 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. | Participants completing both sessions with pre- and post-treatment data are reported. | Posted | Mean | Standard Deviation | score on a scale | baseline to 60 minutes |
|
|
|
| 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. | Participants completing both sessions with pre- and post-treatment data are reported. | Posted | Mean | Standard Deviation | score on a scale | baseline to 60 minutes |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | milliseconds | 30 minutes after alcohol administration |
|
|
|
| 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. | Participants completing both sessions with pre- and post-treatment data are reported. | Posted | Mean | Standard Deviation | number of drinks | baseline to 60 minutes |
|
|
|
| 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. | Participants completing both sessions with pre- and post-treatment data are reported. | Posted | Mean | Standard Deviation | score on a scale | baseline to 60 minutes |
|
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|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | Participants who received a placebo supplement (Aspartame sweetener mixed with water + aspartame capsule). Participants also received a drink containing alcohol (vodka + cranberry mixer) on both sessions. Aspartame Placebo Supplement: Aspartame sweetener mixed with water + aspartame capsule Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions | 0 | 42 | 0 | 42 | 0 | 42 |
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| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |