NCT06715163

Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: AB Biotek · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to evaluate the safety and tolerability of the product administered, of 3 different doses. Safety will be evaluated by recording and assessing adverse events, vital signs, laboratory tests and ECG. These assessments will be conducted during the study and at the end the study, following the study schedule and evaluation times. Since it is not absorbed and considering the conducted studies, 24 h are sufficient to analyse the safety and tolerability of the product. Safety will be assessed until the follow up visit, 6-8 days after product intake, to check possible adverse effects during that time.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dose 1 (42mg) of DAO	DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study
DIETARY_SUPPLEMENT	Placebo	Contains the same excipients as the DAO tablets but without the diamino oxidase content
DIETARY_SUPPLEMENT	Dose 2 (84mg) of DAO	DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study
DIETARY_SUPPLEMENT	Dose 3 (210mg) of DAO	DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

Timeline

• Start date: 2024-07-08
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2024-12-04
• Last updated: 2025-05-30

Locations

1 site across 1 country: Spain