T51
Conditions
Interventions
Group 1: Alcodetox (probiotic food supplement) 600mg probiotic material for 7 days in the morning for breakfast.
Group 2: Placebo (capsules with rice flour) 7 days in the morning for breakfast
Sponsors
Peradil AB
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Investigation of the effect of the dietary supplement in comparison to placebo on: • breath alcohol levels after uptake of a high alcoholic beverage • cognitive function after uptake of a high alcoholic beverage • tolerability of the supplement (type and number of adverse events) | — |
Countries
Germany
Outcome results
None listed