Prospective randomized Study to Assess the Impact of a Single Dose of a Nutritional Supplement (AlcoDetox) on Alcohol Absorption in Healthy Subjects

Not Applicable

• Conditions: T51; Toxic effect of alcohol

• Registration Number: DRKS00024022
• Lead Sponsor: Peradil AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Study Completion: 2021-02-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Preferably participant of study PERA-ATX-001
and/or new participants fulfilling the following criteria:
2. Age > 18 years and = 65 years
3. Caucasian
4. Not suffering from any major disease
5. Willing to perform the two drinking experiments
6. No alcohol consumption within 3 days prior to study participation (negative EtG urine test)
7. Negative Drug Screening test
8. Negative pregnancy test
9. Negative Corona-Test (PCR-Test to be done at study site)

Exclusion Criteria

1. Acute or chronic disease
2. Present or History of alcohol addiction
3. Known allergy against probiotic nutritional supplements
4. Participation in another clinical trial.
5. Progressive fatal diseases
6. Participants taking medication (including non-prescription drugs)
7. Participants taking other dietary supplements
8. Past or current drug or alcohol abuse
9. Pregnancy or breast feeding
10. Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine the effect of AlcoDeTox on blood alcohol levels in a cross-over study comparing AlcoDetox with placebo. In two study visits, after ingestion of a single dose of either AlcoDetox or placebo, blood alcohol levels will be measured at 13 time points over 420 min by means of a blood draw and a laboratory measurement for comparison after completion of the study.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are to study the effect of a single dose of the supplement compared with placebo in a cross-over study on:<br><br>- breath alcohol level after ingestion of a high-alcohol beverage, measured at 13 time points over 420 min with a breath alcohol tester.<br>- The cognitive function after ingestion of alcohol. For this purpose, a cognitive solved task before ingestion of the alcohol is compared with a comparable cognitive solved task 1 h after ingestion of the alcohol. <br>- Tolerability of the supplement (type and number of adverse events). Retrospective after completion of the study.