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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
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).
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
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.
Time frame: 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).
Time frame: 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).
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Dietary habits
Dietary habits assessed through a dietary weekly record
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Histamine in 24h urine
Histamine in 24h urine
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Hemogram
Hemogram
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Glycemia
Glycemia for safety assessment
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HbA1c
HbA1c for safety assessment
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Ionogram
Ionogram for safety assessment
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Lipid profile
Lipid profile
Time frame: 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
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Interleukin-6
Interleukin-6 for safety assessment
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Proteinuria
Proteinuria from urine sample
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".
Urinary pH
Urinary pH to assess renal function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At "baseline or day 1", "day 14", "day 28", "day 42", "day 56" and "day 70".