Clinical Study to Assess the Impact of a Bacterial- and Yeast-based Nutritional Supplement (AlcoDeTox) on Ethyl Alcohol Absorption in the Intestine Tract

Not Applicable

• Conditions: T51; Toxic effect of alcohol

• Registration Number: DRKS00023744
• Lead Sponsor: Peradil AB

Brief Summary

There was a significant reduction of blood alcohol levels by 70.3 % (p < 0.005) with AB001, when compared to placebo. There was a less pronounced but also significant reduction of alcohol in the breath test 30.7 % (p < 0.005), when compared to placebo. No difference in the cognitive function test between AB001 and placebo could be observed 60 min after alcohol ingestion (22.4±7.7 s vs. 22.7±5.6, n.s.). The supplement uptake was well tolerated. There were no adverse events or serious adverse events reported in this study

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-18
• Study Start: 2020-12-01
• Results First Posted: 2022-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Age > 18 years and = 75 years
2. Caucasian
3. Not suffering from any major disease
4. Willing to perform the two drinking experiments
5. No alcohol consumption within 7 days prior to study participation (negative EtG urine test
6. Negative Drug Screening test
7. Negative pregnancy test

Exclusion Criteria

1. Acute or chronic disease
2. Present or History of alcohol addiction
3. Known allergy against probiotic nutritional supplements
4. Participation in a clinical trial within 3 months before trial entry.
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
Primary objective will be the impact of AlcoDeTox on plasma levels of alcohol after uptake of a high alcoholic beverage as compared to placebo after 7 days of nutritional intervention.

Secondary Outcome Measures

Name	Time	Method
Investigation of the effect of the dietary supplement in comparison to placebo on:<br>• breath alcohol levels after uptake of a high alcoholic beverage<br>• cognitive function after uptake of a high alcoholic beverage<br>• tolerability of the supplement (type and number of adverse events)