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

NCT07027943 | Completed

• 1 other identifier: DAO-SLEEP-2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

insomnia; diamine oxidase (DAO); DAO supplementation; double-blind; placebo-controlled

Outcome Measures

Primary Outcomes (1)

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale

  Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 28. A higher score indicates a worse outcome (severity of insomnia).

  Visit day 0, day 7, day 14, day 21 and day 28.

Secondary Outcomes (29)

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale

  Visit day 0, day 7, day 14, day 21 and day 28.

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Insomnia Severity Index (ISI) scale

  Visit day 0, day 7, day 14, day 21 and day 28.

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale

  Visit day 0, day 7, day 14, day 21 and day 28.

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale

  Visit day 0, day 7, day 14, day 21 and day 28.

• Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions by at least one point in the Pittsburgh Sleep Quality Index (PSQI) scale

  Visit day 0 and day 28.

Study Arms (4)

DAO; once per day

EXPERIMENTAL

Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day); once per day.

Dietary Supplement: DAO supplement

Placebo; once per day

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

DAO; 3 times per day

EXPERIMENTAL

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.

Dietary Supplement: DAO supplement

Placebo, 3 times per day

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

DAO supplement DIETARY_SUPPLEMENT

Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).

DAO; 3 times per day; DAO; once per day

Placebo DIETARY_SUPPLEMENT

Tablets containing microcrystalline cellulose and hydroxypropyl cellulose, with the same shape, size, and color as the DAO-containing tablets. Posology: 3 tablets per day.

Placebo, 3 times per day; Placebo; once per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• 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

You may not qualify if:

• Insomnia symptoms referred by patients that might be explained by other co-morbid sleep disorders, e.g., narcolepsy, circadian rhythm disturbances, parasomnia, etc.
• 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.

Sponsors & Collaborators

• AB Biotek: lead
• AdSalutem Sleep Institute: collaborator

Study Sites (1)

AdSalutem Sleep Institute

Barcelona, Barcelona, 08008, Spain

Location

Related Publications (1)

• Ferrer-Garcia J, Navarro MD, Abadias M, Lopez-Garcia R, Sansalvador A, Gris G, Uscamaita K. Effect of diamine oxidase (DAO) enzyme dietary supplementation in subjects with insomnia symptoms and single nucleotide polymorphisms of the AOC1 gene: a randomized double-blind placebo-controlled study. Sleep Med X. 2025 Dec 1;11:100167. doi: 10.1016/j.sleepx.2025.100167. eCollection 2026 Dec.

  PMID: 41437955 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karol Enrique Uscamaita Amaut, MD

  AdSalutem Sleep Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 19, 2025
• Study Start: March 13, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: According to legislation

Locations

ES (1)