NCT06106620

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

Effects of a Multi-Ingredient Dietary Supplement Consisting of Vitamins, Minerals, Botanicals, and Nootropics on Blood and Breath Alcohol Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: The Center for Applied Health Sciences, LLC · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo drink consisting of 12 oz of flavor-matched water.
DIETARY_SUPPLEMENT	Safety Shot	Safety Shot consisting of a 12 oz drink containing vitamins, mineral, and botanical extracts.

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-04-20
• Completion: 2024-04-20
• First posted: 2023-10-30
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States