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

Prospective randomized Study to Assess the Impact of a Single Dose of a Nutritional Supplement (AlcoDetox) on Alcohol Absorption in Healthy Subjects - PERA-ATX-002

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024022

Enrollment

Registered

2021-01-07

Start date

2021-01-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T51

Interventions

Group 1: Alcodetox (probiotic food supplement) 600mg probiotic material at the respective experimental visit Group 2: Placebo (rice flour) 600 mg at the respective experimental visit

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary objectives are to study the effect of a single dose of the supplement compared with placebo in a cross-over study on: - breath alcohol level after ingestion of a high-alcohol beverage, measured at 13 time points over 420 min with a breath alcohol tester. - 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. - Tolerability of the supplement (type and number of adverse events). Retrospective after completion of the study.	—

Measure

Time frame

Secondary objectives are to study the effect of a single dose of the supplement compared with placebo in a cross-over study on: - breath alcohol level after ingestion of a high-alcohol beverage, measured at 13 time points over 420 min with a breath alcohol tester. - 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. - Tolerability of the supplement (type and number of adverse events). Retrospective after completion of the study.

—

Countries

Germany

Contacts

Public ContactSilvia Scherer

Pfützner Science & Health Institute GmbH

info@pfuetzner-mainz.com+49 6131 5884640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026