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

NCT07027943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-06-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • AdSalutem Sleep Institute

    collaborator OTHER

  • AB Biotek

    lead INDUSTRY

Principal Investigators

  • Karol Enrique Uscamaita Amaut, MD · AdSalutem Sleep Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2024-12-18
Completion
2024-12-18

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07027943 on ClinicalTrials.gov