Effects of a Multi-Ingredient Dietary Supplement on Blood and Breath Alcohol Levels

Last updated: May 14, 2024
Sponsor: The Center for Applied Health Sciences, LLC
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Safety Shot

Placebo

Clinical Study ID

NCT06106620
SS-1023-001
  • Ages 21-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 bloodpressure < 90 mm Hg. If the first measurement is slightly elevated above theselimits, the subject will be given a brief (5 minute) rest period, and two moremeasurements will be taken. The average of all three measurements will be used todetermine eligibility.

  • 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 prioreach 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 patternsthroughout the study period.

  • Subject is willing and able to comply with the study protocol.

Exclusion

Exclusion Criteria:

  • History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renaldisease.

  • Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10drinks 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.

  • 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 gastrointestinaldisorder that may impact nutrient absorption e.g., short bowel syndrome, atrophicgastritis, 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'sDisease, 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 postpartumor nursing women. Women who participate in this study must agree to the use ofcontraception for the duration of the study and any woman that is sexually activewill have to take a negative pregnancy test prior to enrolling. Women ofchildbearing age (any woman prior to menopause) regardless of their use ofcontraception will be provided a urine pregnancy test kit at their screening visitand take the test in private using the female lavatory after signing an informedconsent.

  • Known sensitivity to any ingredient in the test formulations as listed in theproduct label.

  • Any other diseases or conditions that, in the opinion of the medical staff, couldconfound the primary endpoints or place the subject at increased risk of harm ifthey were to participate.

Study Design

Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Safety Shot
Phase:
Study Start date:
December 30, 2023
Estimated Completion Date:
April 20, 2024

Study 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.

Connect with a study center

  • The Center for Applied Health Sciences

    Canfield, Ohio 44406
    United States

    Site Not Available

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