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| Name | Class |
|---|---|
| AdSalutem Sleep Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, stratified by the SNP variants of AOC1 gene. Score goes from 0 to 28. A higher score indicates a worse outcome (severity of insomnia). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karol Enrique Uscamaita Amaut, MD | AdSalutem Sleep Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdSalutem Sleep Institute | Barcelona | Barcelona | 08008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41437955 | Derived | 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. |
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ISI score and PSQI score
According to legislation
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| 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. |
|
| 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 | 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, stratified by the use of insomnia pharmacological treatment (benzodiazepines, melatonin, others, or no pharmacological treatment). 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. |
| Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale | Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions 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. |
| Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale | Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Insomnia Severity Index (ISI) scale after one month of DAO supplementation, compared to the placebo group, stratified by the SNP variants of AOC1 gene. 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. |
| 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 | 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 after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 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 | 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 after one month of DAO supplementation, compared to the placebo group, stratified by the SNP variants of AOC1 gene. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 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 | 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 after one month of DAO supplementation, compared to the placebo group, stratified by the use of insomnia pharmacological treatment (benzodiazepines, melatonin, others, or no pharmacological treatment). Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Pittsburgh Sleep Quality Index (PSQI) scale | Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Pittsburgh Sleep Quality Index (PSQI) scale after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Pittsburgh Sleep Quality Index (PSQI) scale | Number (absolute and percentage) of patients who improve their symptoms of insomnia and daytime repercussions in the Pittsburgh Sleep Quality Index (PSQI) scale after one month of DAO supplementation, compared to the placebo group, stratified by the SNP variants of AOC1 gene. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who reduce at least one point on Component 2 (Sleep latency) of the Pittsburgh Sleep Quality Index (PSQI) scale | Number (absolute and percentage) of patients who reduce at least one point on Component 2 (Sleep latency) of the Pittsburgh Sleep Quality Index (PSQI) scale, after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who reduce at least one point on Component 5 (Sleep disturbance) of the Pittsburgh Sleep Quality Index (PSQI) scale | Number (absolute and percentage) of patients who reduce at least one point on Component 5 (Sleep disturbance) of the Pittsburgh Sleep Quality Index (PSQI) scale, after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who reduce at least one point on Component 7 (Daytime dysfunction) of the Pittsburgh Sleep Quality Index (PSQI) scale | Number (absolute and percentage) of patients who reduce at least one point on Component 7 (Daytime dysfunction) of the Pittsburgh Sleep Quality Index (PSQI) scale, after one month of DAO supplementation, compared to the placebo group. Score goes from 0 to 21. A higher score indicates a worse outcome in sleep quality. | Visit day 0 and day 28. |
| Serum DAO activity levels | Mean increase of serum DAO activity levels after one month of DAO supplementation, compared to the placebo group. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who increase their serum DAO activity levels | Number (absolute and percentage) of patients who increase their serum DAO activity levels after one month of DAO supplementation, compared to the placebo group | Visit day 0 and day 28. |
| Mean DAO baseline activity levels | Mean DAO baseline activity levels stratified by the SNP variants of AOC1 gene. | Visit day 0 and day 28. |
| Mean increase in DAO activity levels | Mean increase in DAO activity levels, after one month of DAO supplementation, compared to the placebo group, stratified by the SNP variants of AOC1 gene. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who improve their symptoms associated with histamine intolerance due to DAO deficiency | Number (absolute and percentage) of patients who improve their symptoms associated with histamine intolerance due to DAO deficiency, after one month of DAO supplementation, compared to the placebo group. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients who refer improvement in their daytime repercussions of insomnia | Number (absolute and percentage) of patients who refer improvement in their daytime repercussions of insomnia (such as drowsiness, fatigue, cognitive deficit, lack of concentration, lack of attention or memory, mood swings, and/or headaches) after one month of DAO supplementation, compared to the placebo group. | Visit day 0, day 7, day 14, day 21 and day 28. |
| Number (absolute and percentage) of patients in the once-a day groups 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 in the once-a day groups who improve their symptoms of insomnia and daytime repercussions by at least one point in the ISI scale after one month of DAO supplementation compared to placebo. 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. |
| Percentage of doses taken of DAO supplementation | Percentage of doses taken of DAO supplementation over one month period (counting leftover medication and with patient interview) in the once-a-day groups compared to placebo. | Visit day 0 and day 28. |
| Number (absolute and percentage) of patients in the three times per day groups 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 in the three times per day groups 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 placebo. 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. |
| Percentage of doses taken of DAO supplementation | Percentage of doses taken of DAO supplementation over one month period (counting leftover medication and with patient interview) in the three times per day groups compared to placebo | Visit day 0 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 | 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 in the once-a-day group compared to the three times per day 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. |
| Percentage of doses taken of DAO supplementation | Percentage of doses taken of DAO supplementation over one month period (counting leftover medication and with patient interview) in the once-a-day groups compared to three times per day. | Visit day 0 and day 28. |
| Percentage of compliant patients | Percentage of compliant patients (compliance percentage > 80%) over one month period (counting leftover medication and with patient interview) in the once-a-day groups compared to placebo. | Visit day 0 and day 28. |
| Percentage of compliant patients | Percentage of compliant patients (compliance percentage > 80%) over one month period (counting leftover medication and with patient interview) in the three times per day groups compared to placebo. | Visit day 0 and day 28. |
| Percentage of doses taken of DAO supplementation | Percentage of doses taken of DAO supplementation over one month period (counting leftover medication and with patient interview) in the once-a-day group compared with the three times per day group. | Visit day 0 and day 28. |
| Percentage of compliant patients | Percentage of compliant patients (compliance percentage > 80%) over one month period (counting leftover medication and with patient interview) in the once-a-day group compared with the three times per day group. | Visit day 0 and day 28. |
| Report of adverse events | Report of adverse events after one month of DAO supplementation, compared to the placebo group. | Visit day 0, day 7, day 14, day 21 and day 28. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |