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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
108
Gastro-resistant DAO tablets of porcine kidney protein extract. Posology: 3 tablets per day (total 12.6mg of DAO extract/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.
AdSalutem Sleep Institute
Barcelona, Barcelona, Spain
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).
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
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).
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
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).
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
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).
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
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).
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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
Time frame: Visit day 0 and day 28.
Mean DAO baseline activity levels
Mean DAO baseline activity levels stratified by the SNP variants of AOC1 gene.
Time frame: 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.
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
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.
Time frame: 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.
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
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).
Time frame: 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.
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
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).
Time frame: 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
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit day 0, day 7, day 14, day 21 and day 28.
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