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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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The present study was conducted to assess the safety and tolerability of five ascending doses of plant-based DAO enzyme supplement in subjects with symptoms of histamine intolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (4.2 mg adiDAO®Veg) | Experimental | Patients receive the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks. |
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| Phase 2 (8.4 mg adiDAO®Veg) | Experimental | If, after phase 1, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 8.4 mg of adiDAO®Veg three times a day. |
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| Phase 3 (16.8 mg adiDAO®Veg) | Experimental | If, after phase 2, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 16.8 mg of adiDAO®Veg three times a day. |
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| Phase 4 (33.6 mg adiDAO®Veg) | Experimental | If, after phase 3, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 33.6 mg of adiDAO®Veg three times a day. |
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| Phase 5 (67.2 mg adiDAO®Veg) | Experimental | If, after phase 4, the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose to 67.2 mg of adiDAO®Veg three times a day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diamino Oxidase | Dietary Supplement | The investigational product is a dehydrated power of DAO enzyme from green pea (Pisum sativum L.) sprouts (adiDAO®Veg, DR Healthcare, S.L.U., Barcelona, Spain), with an enzymatic activity > 298 mU/g (> 14,500 kHDU/g). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events (AEs) | Number of participants with treatment-related adverse events (AEs) experienced during the supplementation, assessed through a questionnaire. | At "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Type of adverse effects (AEs) | Symptoms of adverse effects (AEs) experienced during the supplementation, assessed through a questionnaire including the different body systems: gastrointestinal, CNS, respiratory, dermatological). | At "day 14", "day 28", "day 42", "day 56" and "day 70". |
| DAO enzymatic activity in serum using a radioextraction immunoassay | DAO enzymatic activity in serum (mU/mL) using a radioextraction immunoassay (REA-3H, Laboratorio Echevarne, Barcelona, Spain). | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits | Dietary habits assessed through a dietary weekly record | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Histamine in 24h urine | Histamine in 24h urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
Serum DAO activity, participant-reported adverse effects (AEs).
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After signing the informed consent, participants start taking the standard dose of 4.2 mg of adiDAO®Veg three times a day for a period of 2 weeks (phase 1). If the measured DAO enzyme activity levels remain unnormalized, supplementation is continued for a further 2 weeks doubling the dose (8.4 mg) (phase 2), and repeating the process of doubling doses (16.8 mg) (phase 3), 33.6 mg (phase 4), and 67.2 mg (phase 5).
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| At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Hemogram | Hemogram | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Glycemia | Glycemia for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| HbA1c | HbA1c for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Ionogram | Ionogram for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Lipid profile | Lipid profile | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| C-reactive protein | C-reactive protein for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Interleukin-6 | Interleukin-6 for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Proteinuria | Proteinuria from urine sample | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Urine sediment | Urine sediment from urine sample for safety assessment | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Gastrointestinal symptoms through Rome IV criteria | Self-reported Gastrointestinal symptoms: Rome IV criteria | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Gastrointestinal symptoms through Bristol Stool Scale | Self-reported Gastrointestinal symptoms: Bristol Stool Scale. Score goes from Type 1 to Type 7. Higher and lower scores mean worse outcome. Middle scores (Type 3-4) are considered normal/healthy stool consistency. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Gastrointestinal symptoms through Gastrointestinal Quality of Life Index (GIQLI) | Self-reported Gastrointestinal symptoms: Gastrointestinal Quality of Life Index (GIQLI). Score goes from 0 to 144. Higher scores indicate a better outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Headaches symptoms through MIDAS questionnaire | Self-reported Headaches symptoms through Migraine Disability Assessment Questionnaire (MIDAS) questionnaire. Score goes from 0 to >21 points. Higher scores indicate a worse outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Headaches symptoms through HIT-6 questionnaire | Self-reported Headaches symptoms through Headache Impact Test-6 (HIT-6) questionnaire. Score goes from 36 to 78. Higher scores indicate a worse outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Respiratory symptoms through SNOT-22 questionnaire | Self-reported respiratory symptoms through Sino-Nasal Outcome Test-22 (SNOT-22) questionnaire. Score goes from 0 to 110. Higher scores indicate a worse outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Score goes from 0 to 6. Higher scores indicate a worse outcome. | Self-reported respiratory symptoms through Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Dermatological symptoms through SCORAD index | Self-reported dermatological symptoms through SCORing Atopic Dermatitis (SCORAD) index. Score goes from 0 to 103. Higher scores indicate a worse outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Dermatological symptoms through Itch Severity Scale (ISS) | Self-reported dermatological symptoms through Itch Severity Scale. Score goes from 0 to 21. Higher scores indicate a worse outcome | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Dermatological symptoms through Dermatology Life Quality Index (DLQI) | Self-reported dermatological symptoms through Dermatology Life Quality Index (DLQI). Score goes from 0 to 20. Higher scores indicate worse outcomes. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Short-Form Health Survey (SF-36) | Self-reported Short-Form Health Survey (SF-36) Quality of Life. Score goes from 0 to 100. Higher scores indicate a better outcome. | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Creatinine (mg/dL) | Creatinine (mg/dL) to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Glomerular filtration rate (mL/min/1.73m2) | Glomerular filtration rate (mL/min/1.73m2) to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Uric acid (mg/dL) | Uric acid (mg/dL) to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Albuminuria (mg/L) | Albuminuria (mg/L) to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Albumin/creatinine ratio | Albumin (mg/L)/creatinine (mg/dL) ratio; to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Urine (mg/g) | Urine (mg/g) ratio; to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Urinary pH | Urinary pH to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Urine specific gravity (g/mL) | Urine specific gravity (g/mL) to assess renal function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Aspartate Aminotransferase, ASAT (U/L) | Aspartate Aminotransferase, ASAT (U/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Alanine Aminotransferase, ALAT (U/L) | Alanine Aminotransferase, ALAT (U/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Gamma-Glutamyl Transferase, GGT (U/L) | Gamma-Glutamyl Transferase, GGT (U/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Total Bilirubin (mg/dL) | Total Bilirubin (mg/dL) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Alkaline Phosphatase (U/L) | Alkaline Phosphatase (U/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Lactate Dehydrogenase (U/L) | Lactate Dehydrogenase (U/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Total Proteins (g/L) | Total Proteins (g/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |
| Albumin (g/L) | Albumin (g/L) to assess hepatic function | At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70". |