Alcohol DrinkingSatTACNCT06576674
Satiety and Alcohol Challenge
A study testing Dietary Fiber + Green Tea Extract and Alcohol in people with Alcohol Drinking, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Dietary Fiber + Green Tea Extract and Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge
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.
Read the 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.
- Conditions
- Alcohol Drinking
- Being tested
- Dietary Fiber + Green Tea Extract, Alcohol, Aspartame Placebo Supplement
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Fiber + Green Tea ExtractDietary supplement
Also called Fibersol®-2, decaffeinated green tea extract
10g fiber + 750mg green tea supplement will be administered at experimental arm
AlcoholOther
Also called ethanol (ETOH)
alcohol administered up to a target BAC 0.06g/dL during lab sessions
Aspartame Placebo SupplementOther
Also called Equal
Aspartame sweetener mixed with water + aspartame capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Dietary Fiber + Green Tea Extract; Other: Alcohol; Other: Aspartame Placebo Supplement |
| 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. Receives: Dietary Supplement: Dietary Fiber + Green Tea Extract; Other: Alcohol; Other: Aspartame Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 60 minutes
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start3 Sep 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- within-subjects placebo-controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Research Society on Alcohol, North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Jimikaye Courtney, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576674
- Sponsor's protocol ID
- 24-1095
- Acronym
- SatTAC
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2024
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dietary Supplement on Satiety and Acute Responses to Laboratory Alcohol Challenge
- ClinicalTrials.gov ID
- NCT06576674
- Acronym / sponsor ID
- SatTAC / 24-1095
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Research Society on Alcohol, North Carolina Translational and Clinical Sciences Institute
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 29 Aug 2024 (actual)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- within-subjects placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| dietary supplement, then placebo | Experimental | Dietary Supplement: Dietary Fiber + Green Tea Extract, Other: Alcohol, Other: Aspartame Placebo SupplementParticipants 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 | Dietary Supplement: Dietary Fiber + Green Tea Extract, Other: Alcohol, Other: Aspartame Placebo SupplementParticipants 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Fiber + Green Tea ExtractAlso: Fibersol®-2, decaffeinated green tea extract10g fiber + 750mg green tea supplement will be administered at experimental arm | Dietary supplement | dietary supplement, then placebo, placebo, then dietary supplement |
| AlcoholAlso: ethanol (ETOH)alcohol administered up to a target BAC 0.06g/dL during lab sessions | Other | dietary supplement, then placebo, placebo, then dietary supplement |
| Aspartame Placebo SupplementAlso: EqualAspartame sweetener mixed with water + aspartame capsule | Other | dietary supplement, then placebo, placebo, then dietary supplement |
Primary outcome
Change in Alcohol Specific Satiety Score
Time frame: 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.
5 secondary outcomes
Change in Positive Affect Based on Subjective Effects of Alcohol Scale Score
Time frame: baseline to 60 minutes
Change in Subjective Stimulation (Biphasic Alcohol Effects Scale)
Time frame: baseline to 60 minutes
Change in Attention Bias to Alcohol Score
Time frame: 30 minutes after alcohol administration
Change in Alcohol Demand Score
Time frame: baseline to 60 minutes
Change in Alcohol Urge Questionnaire Score
Time frame: baseline to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimikaye Courtney, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber + Green Tea Extract and Alcohol in people with Alcohol Drinking, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Specific Satiety Score (time frame: baseline to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.