Trial Outcomes & Findings for Satiety and Alcohol Challenge (NCT NCT06576674)
NCT ID: NCT06576674
Last Updated: 2025-12-05
Results Overview
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.
COMPLETED
NA
64 participants
baseline to 60 minutes
2025-12-05
Participant Flow
Of the 64 individuals who signed informed consent, 44 participants were randomized to 1 of 2 intervention arms.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention Session (6 Hours)
STARTED
|
23
|
21
|
|
First Intervention Session (6 Hours)
COMPLETED
|
23
|
21
|
|
First Intervention Session (6 Hours)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Days)
STARTED
|
23
|
21
|
|
Washout (2 Days)
COMPLETED
|
21
|
19
|
|
Washout (2 Days)
NOT COMPLETED
|
2
|
2
|
|
Second Intervention Session (6 Hours)
STARTED
|
21
|
19
|
|
Second Intervention Session (6 Hours)
COMPLETED
|
21
|
19
|
|
Second Intervention Session (6 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Satiety and Alcohol Challenge
Baseline characteristics by cohort
| Measure |
All Participants
n=44 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.
|
|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 6.5 • n=9 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: baseline to 60 minutesPopulation: Participants completing both sessions with pre- and post-treatment data are reported.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=40 Participants
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
|
|---|---|---|
|
Change in Alcohol Specific Satiety Score
|
-0.51 score on a scale
Standard Deviation 5.25
|
4.85 score on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: baseline to 60 minutesPopulation: Participants completing both sessions with pre- and post-treatment data are reported.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=40 Participants
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
|
|---|---|---|
|
Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score
|
2.59 score on a scale
Standard Deviation 0.98
|
2.84 score on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: baseline to 60 minutesPopulation: Participants completing both sessions with pre- and post-treatment data are reported.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=40 Participants
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
|
|---|---|---|
|
Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)
|
0.05 score on a scale
Standard Deviation 1.05
|
0.05 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 30 minutes after alcohol administrationPopulation: 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.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=39 Participants
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
|
|---|---|---|
|
Change in Attention Bias to Alcohol Score
|
-15.5 milliseconds
Standard Deviation 45.3
|
6.63 milliseconds
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: baseline to 60 minutesPopulation: Participants completing both sessions with pre- and post-treatment data are reported.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=40 Participants
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
|
|---|---|---|
|
Change in Alcohol Demand Score
|
-0.15 number of drinks
Standard Deviation 1.67
|
0.00 number of drinks
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: baseline to 60 minutesPopulation: Participants completing both sessions with pre- and post-treatment data are reported.
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.
Outcome measures
| Measure |
Dietary Supplement
n=40 Participants
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 will be administered at experimental arm
Alcohol: alcohol administered up to a target BAC 0.06g/dL during lab sessions
|
Placebo
n=40 Participants
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
|
|---|---|---|
|
Change in Alcohol Urge Questionnaire Score
|
3.66 score on a scale
Standard Deviation 7.43
|
3.31 score on a scale
Standard Deviation 4.37
|
Adverse Events
Dietary Supplement
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Bremmer, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place