Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT06106620
Brief 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.
Study:
NCT06106620
Study Brief:
Protocol Section:
NCT06106620