NCT07027943

Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AB Biotek · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Considering the high prevalence of DAO enzyme deficiency in patients referring insomnia symptoms, it would be plausible that the appearance of insomnia symptoms were explained by the DAO enzyme deficiency. One of the strategies to revert DAO enzyme deficiency would be to supplement patients with DAO enzyme, helping at recovering the normal DAO levels. Therefore, the objective of the present study is to evaluate the effect of DAO enzyme supplementation on the insomnia symptoms characteristics in patients with insomnia symptoms and genetic DAO deficiency as expected from bearing at least one of the 4 above-mentioned SNPs of the AOC1 gene.

Conditions

• Insomnia
• Insomnia Type; Sleep Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DAO supplement	Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).
DIETARY_SUPPLEMENT	Placebo	Tablets containing microcrystalline cellulose and hydroxypropyl cellulose, with the same shape, size, and color as the DAO-containing tablets. Posology: 3 tablets per day.

Timeline

• Start date: 2024-03-13
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Spain