Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms
NCT ID: NCT07027943
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2024-03-13
2024-12-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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DAO; once per day
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day); once per day.
DAO supplement
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).
Placebo; once per day
Tablets containing microcrystalline cellulose and hydroxypropyl cellulose, with the same shape, size, and color as the DAO-containing tablets.
Posology: 3 tablets per day, once per day.
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.
DAO; 3 times per day
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day) in 3 different times per day.
DAO supplement
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).
Placebo, 3 times per day
Tablets containing microcrystalline cellulose and hydroxypropyl cellulose, with the same shape, size, and color as the DAO-containing tablets. Posology: 3 tablets per day in 3 different times per day.
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.
Interventions
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DAO supplement
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).
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.
Eligibility Criteria
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Inclusion Criteria
* With the ability to understand and sign informed consent reviewed and approved by the Grupo Hospitalario Quironsalud-Catalunya.
* That refer one or more symptoms of insomnia, these being: Difficulty initiating sleep, Difficulty maintaining sleep, Waking up early with inability to go back to sleep.
* Who are carriers, either heterozygous or homozygous, of at least one of the following 4 SNPs associated with a reduction in the enzymatic activity of DAO or a decreased transcriptional activity of it: c.47C\>T (rs10156191), c.995C\>T (rs1049742), c.1990C\>G (rs1049793), c.-691G\>T (rs2052129).
* With the ability to attend the foreseen face-to-face and telephonic study visits.
* With the ability to intake the product under study
* Explicit agreement on study participation by reading, understanding, and signing the informed consent reviewed and approved by the Grupo Hospitalario Quironsalud-Catalunya
Exclusion Criteria
* Taking DAO supplementation less than 1 month prior to the start of the study.
* Following a diet low in histamine less than 1 month prior to the start of the study.
* Volunteers with allergies to some of the ingredients of the product under study.
18 Years
ALL
No
Sponsors
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AdSalutem Sleep Institute
OTHER
AB Biotek
INDUSTRY
Responsible Party
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Principal Investigators
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Karol Enrique Uscamaita Amaut, MD
Role: PRINCIPAL_INVESTIGATOR
AdSalutem Sleep Institute
Locations
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AdSalutem Sleep Institute
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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DAO-SLEEP-2023
Identifier Type: -
Identifier Source: org_study_id
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