Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers (DAO-MAX2024)

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.

Study Overview

• Status: Completed
• Conditions: Safety and Tolerability in Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Dose 1 (42mg) of DAO; Dietary supplement: Placebo; Dietary supplement: Dose 2 (84mg) of DAO; Dietary supplement: Dose 3 (210mg) of DAO

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. - Background of allergy, idiosyncrasy or hypersensitivity to Investigational or any products or food
2. - Heavy consumers of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks per day).
3. - 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.
4. - 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.
5. - Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
6. - Positive results for abuse drugs in urine test or ethanol in breath test (Day-1).
7. - Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, haematological, neurological disease or other chronic diseases.
8. - Females with positive results from the pregnancy test or breast-feeding.
9. - 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.
10. - Mentally or legally incapacitated at screening.
11. - Unwillingness or inability to follow the procedures outlined in the protocol.
12. - Volunteers who have difficulties in understanding the language in which the volunteer information is given.
13. - Any condition that, in the opinion of the investigator, may jeopardise the patient's well-being or the trial conduct according to the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1 (42mg) of DAO; Lowest dose of DAO administered in this study	Dietary supplement: Dose 1 (42mg) of DAO; DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study; Other Names: diamino oxidase (DAO)
Placebo Comparator: Placebo tablets; placebo tablets	Dietary supplement: Placebo; Contains the same excipients as the DAO tablets but without the diamino oxidase content
Experimental: Dose 2 (84mg) of DAO; Medium dose of DAO administered in this study	Dietary supplement: Dose 2 (84mg) of DAO; DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study
Experimental: Dose 3 (210mg) of DAO; Highest dose of DAO administered in this study	Dietary supplement: Dose 3 (210mg) of DAO; DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs - blood pressure	Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)	from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Heart Rate	Heart rate as bpm (beats per minute)	from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Respiratory Rate	Respiratory rate as bpm	from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - temperature	Body temperature as ºC (Celsius degrees)	from baseline (pre-dose) to 24 hours after treatment administration
ECG - Ventricular Rate (HR)	Electrocardiogram: Ventricular rate (bpm)	from baseline (pre-dose) to 24 hours after treatment administration
ECG - PR interval	Electrocardiogram: PR interval (ms)	from baseline (pre-dose) to 24 hours after treatment administration
ECG - QRS interval	Electrocardiogram: QRS interval (ms)	from baseline (pre-dose) to 24 hours after treatment administration
ECG - QT interval	Electrocardiogram: QT interval (ms)	from baseline (pre-dose) to 24 hours after treatment administration
ECG - QTc interval	Electrocardiogram: QTc interval through Bazett's formula (ms)	from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses	SEROLOGY: HIV, HBV and HCV measured through ELISA analysis as presence or absence (positive or negative result).	from baseline (pre-dose) to 24 hours after treatment administration
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).	from baseline (pre-dose) to 24 hours after treatment administration
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.	from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L	BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L	from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L	BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L	from baseline (pre-dose) to 24 hours after treatment administration
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.	from baseline (pre-dose) to 24 hours after treatment administration
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.	from baseline (pre-dose) to 24 hours after treatment administration
Laboratory analyses - Concentration of Haematocrit as L/L	HAEMATOLOGY: Concentration of Haematocrit as L/L	from baseline (pre-dose) to 24 hours after treatment administration
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.	from baseline (pre-dose) to 24 hours after treatment administration

Collaborators and Investigators

• Sponsor: AB Biotek
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Pol Molina, PharmaD, Institut de Recerca Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: tolerability; safety; supplementation; DAO; diamino oxidase
• Other Study ID Numbers: DAO-MAX2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Safety and tolerability of the treatments will be evaluated by assessing vital signs, laboratory analyses, ECG and incidence of AE.
• IPD Sharing Time Frame: According to legislation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No