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CompletedNCT06715163DAO-MAX2024Updated May 30, 2025

Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers

An interventional study of Dose 1 (42mg) of DAO and Placebo in Safety and Tolerability in Healthy Volunteers, sponsored by AB Biotek. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by AB Biotek · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2024, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The main aim of this study is to evaluate the safety and tolerability of the product administered, of 3 different doses. Safety will be evaluated by recording and assessing adverse events, vital signs, laboratory tests and ECG. These assessments will be conducted during the study and at the end the study, following the study schedule and evaluation times. Since it is not absorbed and considering the conducted studies, 24 h are sufficient to analyse the safety and tolerability of the product. Safety will be assessed until the follow up visit, 6-8 days after product intake, to check possible adverse effects during that time.

02

Conditions studied

  • Safety and Tolerability in Healthy Volunteers

Keywords

  • safety
  • tolerability
  • diamino oxidase
  • DAO
  • supplementation
03

In context

Lead sponsor

AB Biotek is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • Subjects of either gender (male or female) aged ≥18 and ≤50 years at the time of the enrolment.
    • Subjects free from organic or psychic conditions.
    • No clinically significant abnormalities in medical records and physical examination at screening.
    • No clinically significant abnormalities in haematology, biochemistry, serology (HBsAg, HCV antibodies, HIV antibodies) and urine drug results.
    • Vital signs (blood pressure, respiratory rate, body temperature and pulse rate) and electrocardiogram record without clinically significant abnormalities.
    • Body weight within the range (BMI ≥ 18.5 and ≤30.0 kg/m2) expressed as weight (kg) / height (m2).
    • Free acceptance to participate in the study by obtaining signed informed consent form approved by the Ethics Committee of the Hospital (CEIm).

Exclusion criteria

Exclusion Criteria:

    • Background of allergy, idiosyncrasy or hypersensitivity to Investigational or any products or food
    • Heavy consumers of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
    • Background History of alcohol dependence or drug abuse in the last 5 years or daily consumption of alcohol > 40 gr/day for men or 24 gr/day for women.
    • Intake of any medication within 14 days prior to taking the study treatment (except for use of paracetamol short-term symptomatic treatments, according to the investigator criteria), or intake of over-the-counter products (including natural food supplements, vitamins and medicinal plants products) within 7 days prior taking the study treatment.
    • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
    • Positive results for abuse drugs in urine test or ethanol in breath test (Day-1).
    • Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
    • Females with positive results from the pregnancy test or breast-feeding.
    • Smoking within 6 months prior to the study treatment phase (Period 1, Day -1). Smokers must refrain from any tobacco usage, including smokeless tobacco, nicotine patches, electronic cigarettes, etc. at least for 6 months prior to study treatment.
    • Mentally or legally incapacitated at screening.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    • Volunteers who have difficulties in understanding the language in which the volunteer information is given.
    • Any condition that, in the opinion of the investigator, may jeopardise the patient's well-being or the trial conduct according to the protocol.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Dose 1 (42mg) of DAO

    Lowest dose of DAO administered in this study

    Dietary Supplement: Dose 1 (42mg) of DAO

  • Placebo comparator
    Placebo tablets

    placebo tablets

    Dietary Supplement: Placebo

  • Experimental
    Dose 2 (84mg) of DAO

    Medium dose of DAO administered in this study

    Dietary Supplement: Dose 2 (84mg) of DAO

  • Experimental
    Dose 3 (210mg) of DAO

    Highest dose of DAO administered in this study

    Dietary Supplement: Dose 3 (210mg) of DAO

Interventions

  • Dietary supplementDose 1 (42mg) of DAO

    DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study

    Also known as: diamino oxidase (DAO)

  • Dietary supplementPlacebo

    Contains the same excipients as the DAO tablets but without the diamino oxidase content

  • Dietary supplementDose 2 (84mg) of DAO

    DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study

  • Dietary supplementDose 3 (210mg) of DAO

    DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

06

What researchers measure

Primary outcomes

  1. Vital signs - blood pressure

    Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  2. Vital signs - Heart Rate

    Heart rate as bpm (beats per minute)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  3. Vital signs - Respiratory Rate

    Respiratory rate as bpm

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  4. Vital signs - temperature

    Body temperature as ºC (Celsius degrees)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  5. ECG - Ventricular Rate (HR)

    Electrocardiogram: Ventricular rate (bpm)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  6. ECG - PR interval

    Electrocardiogram: PR interval (ms)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  7. ECG - QRS interval

    Electrocardiogram: QRS interval (ms)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  8. ECG - QT interval

    Electrocardiogram: QT interval (ms)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  9. ECG - QTc interval

    Electrocardiogram: QTc interval through Bazett's formula (ms)

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  10. Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

    BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  11. Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L

    BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  12. Laboratory analyses - Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L

    BIOCHEMISTRY: Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L.

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  13. Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.

    BIOCHEMISTRY: Concentrations of Albumin measured as g/L. HAEMATOLOGY: Concentrations of Haemoglobin, CCMH measured as g/L.

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  14. Laboratory analyses - Concentration of Haematocrit as L/L

    HAEMATOLOGY: Concentration of Haematocrit as L/L

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  15. Laboratory analyses - Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L

    HAEMATOLOGY: Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L.

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  16. Laboratory analyses

    SEROLOGY: HIV, HBV and HCV measured through ELISA analysis as presence or absence (positive or negative result).

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  17. Laboratory analyses

    SCREENING of DRUGS of ABUSE in URINE: ethanol, cannabis, amphetamines, cocaine, opiates and benzodiazepines measured as presence or absence (positive or negative result).

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

  18. Incidence of adverse events

    Assessment through the opinion of the Investigator, who should consider if it is contraindicative to continue the volunteer's participation in the study if the volunteer experienced adverse events severe enough.

    Time frame: from baseline (pre-dose) to 24 hours after treatment administration

07

Study locations

1 site
  • Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Safety and tolerability of the treatments will be evaluated by assessing vital signs, laboratory analyses, ECG and incidence of AE.

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06715163
Lead sponsor
AB Biotek
Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Jul 8, 2024
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024
Last update
May 30, 2025

Study contacts

Pol Molina, PharmaD
principal investigator · Institut de Recerca Sant Pau

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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