Alcohol DrinkingNCT06106620
Effects of a Multi-Ingredient Dietary Supplement on Blood and Breath Alcohol Levels
A study testing Safety Shot in people with Alcohol Drinking, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
Trial summary
This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Safety Shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between the ages of 21 and 55 (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
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- Normal seated, resting heart rate (<90 per minute).
- Willing to duplicate their previous 24-hour diet, refrain from alcohol for 48 hours, caffeine and exercise for 24 hours prior to each trial, and fast for 10 hours prior each of the treatments.
- Agreeable to have a third-party transport home following interventional visits.
- Able to provide an adequate blood draw.
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Subject is willing and able to comply with the study protocol.
Who cannot join
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or history of drug/alcohol abuse or dependence.
- History of diabetes or endocrine disorder.
- Fasting blood sugar of > 125 mg/dL.
- Current smokers or cessation of smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid disease.
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- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (Lapband), etc., known gastrointestinal disorder that may impact nutrient absorption e.g., short bowel syndrome, atrophic gastritis, IBD, diarrheal illnesses, history of colon resection, gastro-paresis, celiac disease, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's Disease, ulcerative colitis, lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of asthma, gout, or fibromyalgia.
- Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
- Known sensitivity to any ingredient in the test formulations as listed in the product label.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: Effects of a Multi-Ingredient Dietary Supplement Consisting of Vitamins, Minerals, Botanicals, and Nootropics on Blood and Breath Alcohol Levels
This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol.
Read the detailed description
This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease.
Participants will attend three study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, and background baseline diet. During Visits 2 and 3 participants will ingest 100 mL (3.4 oz) of 40% alcohol, along with a commercially available liquid blend of dietary supplements or a placebo, and undergo assessments of breath alcohol content, blood alcohol levels, blood alcohol dehydrogenase levels, and various visual analog scales (VAS) for indices of affect (headache, nausea, fatigue, energy, tiredness, thirst, concentration) for 4 hours post-ingestion. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
- Conditions
- Alcohol Drinking
- Being tested
- Placebo, Safety Shot
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo drink consisting of 12 oz of flavor-matched water.
Safety ShotDietary supplement
Safety Shot consisting of a 12 oz drink containing vitamins, mineral, and botanical extracts.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 12 oz of flavor-matched water. Receives: Dietary Supplement: Placebo |
| Safety Shot | Experimental | 12 oz of Safety Shot containing a blend of vitamins, minerals and botanical extracts. Receives: Dietary Supplement: Safety Shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache
Headache as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent a greater headache.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Nausea
Nausea as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater nausea.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Fatigue
Fatigue as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater fatigue.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Energy
Energy as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater energy.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Tiredness
Tiredness as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater tiredness.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Thirst
Thirst as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater thirst.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Concentration
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater concentration.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Secondary outcomes (6)
Breath alcohol level
Breath alcohol level measured in %.
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood alcohol level
Blood alcohol level measured in milligrams per deciliter (mg/dL).
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood alcohol dehydrogenase level
Blood alcohol dehydrogenase level measured picograms per milliliter (pg/mL).
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood acetaldehyde level
Blood acetaldehyde level as measured in milligrams per deciliter (mg/dL).
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood aldehyde dehydrogenase level
Blood aldehyde dehydrogenase level as measured in nanograms per milliliter (ng/mL).
Measured: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Urine volume
Urine volume as measured in milliliters.
Measured: Change from baseline to 60 minutes, 120 minutes, 180 minutes, and 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start30 Dec 2023
- Primary completion20 Apr 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106620
- Sponsor's protocol ID
- SS-1023-001
- Status last verified
- May 2024
- First submitted
- 24 Oct 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-Ingredient Dietary Supplement Consisting of Vitamins, Minerals, Botanicals, and Nootropics on Blood and Breath Alcohol Levels
- ClinicalTrials.gov ID
- NCT06106620
- Acronym / sponsor ID
- SS-1023-001
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol.
Detailed description
This study is a randomized, two-arm, double-blind, placebo-controlled, crossover study of N=36 apparently healthy men and women. This study will assess the effect of a blend of dietary supplements on blood and breath levels after consuming alcohol. Consumption of this dietary supplement is not intended to diagnose, treat, cure, or prevent any disease.
Participants will attend three study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, and background baseline diet. During Visits 2 and 3 participants will ingest 100 mL (3.4 oz) of 40% alcohol, along with a commercially available liquid blend of dietary supplements or a placebo, and undergo assessments of breath alcohol content, blood alcohol levels, blood alcohol dehydrogenase levels, and various visual analog scales (VAS) for indices of affect (headache, nausea, fatigue, energy, tiredness, thirst, concentration) for 4 hours post-ingestion. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo12 oz of flavor-matched water. |
| Safety Shot | Experimental | Dietary Supplement: Safety Shot12 oz of Safety Shot containing a blend of vitamins, minerals and botanical extracts. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between the ages of 21 and 55 (inclusive).
- Body Mass Index of 18.5-34.9 (inclusive).
- Body weight of at least 110 pounds.
Key exclusion criteria (13 listed)
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or history of drug/alcohol abuse or dependence.
- History of diabetes or endocrine disorder.
- Fasting blood sugar of > 125 mg/dL.
- Current smokers or cessation of smoking within the past month.
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 |
|---|---|---|
| PlaceboPlacebo drink consisting of 12 oz of flavor-matched water. | Dietary supplement | Placebo |
| Safety ShotSafety Shot consisting of a 12 oz drink containing vitamins, mineral, and botanical extracts. | Dietary supplement | Safety Shot |
Primary outcome
Headache
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Headache as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent a greater headache.
Nausea
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Nausea as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater nausea.
Fatigue
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Fatigue as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater fatigue.
Energy
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Energy as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater energy.
Tiredness
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Tiredness as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater tiredness.
Thirst
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Thirst as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater thirst.
Concentration
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater concentration.
6 secondary outcomes
Breath alcohol level
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood alcohol level
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood alcohol dehydrogenase level
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood acetaldehyde level
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Blood aldehyde dehydrogenase level
Time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.
Urine volume
Time frame: Change from baseline to 60 minutes, 120 minutes, 180 minutes, and 240 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Shot in people with Alcohol Drinking, run by The Center for Applied Health Sciences, LLC 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 12 inclusion and 13 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 16 May 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Headache (time frame: Change from baseline to 30 minutes, 45 minutes, 60 minutes, 120 minutes, 180 minutes and 240 minutes.). The study lists 7 primary outcomes in all. 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 16 May 2024.