Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms (DAO-SLEEP-2023)

AB Biotek

Status: Completed

Conditions: Insomnia Type; Sleep Disorder; Insomnia

Treatments: Dietary Supplement: DAO supplement; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07027943

DAO-SLEEP-2023

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups, including a placebo group

DAO; once per day

Experimental group

Description:

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

Treatment:

Dietary Supplement: DAO supplement

Placebo; once per day

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

DAO; 3 times per day

Experimental group

Description:

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.

Treatment:

Dietary Supplement: DAO supplement

Placebo, 3 times per day

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo