InsomniaDAO-SLEEP-2023NCT07027943
Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms
A study testing DAO supplement in people with Insomnia and Insomnia Type; Sleep Disorder, run by AB Biotek at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Insomnia Type; Sleep Disorder
- What is being tested?
- DAO supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2024to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- DAO supplement, Placebo
- Keywords
- insomnia, diamine oxidase (DAO), DAO supplementation, double-blind, placebo-controlled
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAO supplementDietary supplement
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day).
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Visit day 0 and day 28.
Mean DAO baseline activity levels
Mean DAO baseline activity levels stratified by the SNP variants of AOC1 gene.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit day 0, day 7, day 14, day 21 and day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start13 Mar 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AdSalutem Sleep Institute
- Responsible party
- Sponsor
- Investigators
- Karol Enrique Uscamaita Amaut, MD, Principal investigator, AdSalutem Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027943
- Sponsor's protocol ID
- DAO-SLEEP-2023
- Acronym
- DAO-SLEEP-2023
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ISI score and PSQI score
Publications
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.
PubMed 41437955
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Diamine Oxidase Supplementation Effect In Patients With Insomnia Symptoms
- ClinicalTrials.gov ID
- NCT07027943
- Acronym / sponsor ID
- DAO-SLEEP-2023 / DAO-SLEEP-2023
- Conditions
- Insomnia, Insomnia Type; Sleep Disorder
- Keywords
- insomnia, diamine oxidase (DAO), DAO supplementation, double-blind, placebo-controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AB BiotekIndustry (pharma, biotech, devices)
- Collaborators
- AdSalutem Sleep Institute
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DAO; once per day | Experimental | Dietary Supplement: DAO supplementGastro-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 | Dietary Supplement: PlaceboTablets 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 | Dietary Supplement: DAO supplementGastro-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 | Dietary Supplement: PlaceboTablets 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAO supplementGastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/day). | Dietary supplement | DAO; 3 times per day, DAO; once per day |
| PlaceboTablets containing microcrystalline cellulose and hydroxypropyl cellulose, with the same shape, size, and color as the DAO-containing tablets. Posology: 3 tablets per day. | Dietary supplement | Placebo, 3 times per day, Placebo; once per day |
Primary outcome
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
Time frame: 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 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).
29 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Visit day 0 and day 28.
Serum DAO activity levels
Time frame: Visit day 0 and day 28.
Number (absolute and percentage) of patients who increase their serum DAO activity levels
Time frame: Visit day 0 and day 28.
Mean DAO baseline activity levels
Time frame: Visit day 0 and day 28.
Mean increase in DAO activity levels
Time frame: Visit day 0 and day 28.
Number (absolute and percentage) of patients who improve their symptoms associated with histamine intolerance due to DAO deficiency
Time frame: Visit day 0 and day 28.
Number (absolute and percentage) of patients who refer improvement in their daytime repercussions of insomnia
Time frame: 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
Time frame: Visit day 0, day 7, day 14, day 21 and day 28.
Percentage of doses taken of DAO supplementation
Time frame: 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
Time frame: Visit day 0, day 7, day 14, day 21 and day 28.
Percentage of doses taken of DAO supplementation
Time frame: 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
Time frame: Visit day 0, day 7, day 14, day 21 and day 28.
Percentage of doses taken of DAO supplementation
Time frame: Visit day 0 and day 28.
Percentage of compliant patients
Time frame: Visit day 0 and day 28.
Percentage of compliant patients
Time frame: Visit day 0 and day 28.
Percentage of doses taken of DAO supplementation
Time frame: Visit day 0 and day 28.
Percentage of compliant patients
Time frame: Visit day 0 and day 28.
Report of adverse events
Time frame: Visit day 0, day 7, day 14, day 21 and day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 41437955Ferrer-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.
- Individual participant dataSharing planned: Yes. ISI score and PSQI score
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karol Enrique Uscamaita Amaut, MD principal investigator
AdSalutem Sleep Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAO supplement in people with Insomnia and Insomnia Type; Sleep Disorder, run by AB Biotek at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Visit day 0, day 7, day 14, day 21 and day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07027943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.