Safety and Tolerability in Healthy VolunteersDAO-MAX2024NCT06715163
Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers
A study testing Dose 1 (42mg) of DAO, Dose 2 (84mg) of DAO and Dose 3 (210mg) of DAO in people with Safety and Tolerability in Healthy Volunteers, run by AB Biotek at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- Dose 1 (42mg) of DAO, Dose 2 (84mg) of DAO and Dose 3 (210mg) of DAO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jul 2024to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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).
Who cannot join
- - 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).
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- - 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
About this study
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.
- Being tested
- Dose 1 (42mg) of DAO, Placebo, Dose 2 (84mg) of DAO, Dose 3 (210mg) of DAO
- Keywords
- safety, tolerability, diamino oxidase, DAO, supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 1 (42mg) of DAODietary supplement
Also called diamino oxidase (DAO)
DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study
PlaceboDietary supplement
Contains the same excipients as the DAO tablets but without the diamino oxidase content
Dose 2 (84mg) of DAODietary supplement
DAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study
Dose 3 (210mg) of DAODietary supplement
DAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 (42mg) of DAO | Experimental | Lowest dose of DAO administered in this study Receives: Dietary Supplement: Dose 1 (42mg) of DAO |
| Placebo tablets | Placebo comparator | placebo tablets Receives: Dietary Supplement: Placebo |
| Dose 2 (84mg) of DAO | Experimental | Medium dose of DAO administered in this study Receives: Dietary Supplement: Dose 2 (84mg) of DAO |
| Dose 3 (210mg) of DAO | Experimental | Highest dose of DAO administered in this study Receives: Dietary Supplement: Dose 3 (210mg) of DAO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs - blood pressure
Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Heart Rate
Heart rate as bpm (beats per minute)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - Respiratory Rate
Respiratory rate as bpm
Measured: from baseline (pre-dose) to 24 hours after treatment administration
Vital signs - temperature
Body temperature as ºC (Celsius degrees)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
ECG - Ventricular Rate (HR)
Electrocardiogram: Ventricular rate (bpm)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
ECG - PR interval
Electrocardiogram: PR interval (ms)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
ECG - QRS interval
Electrocardiogram: QRS interval (ms)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
ECG - QT interval
Electrocardiogram: QT interval (ms)
Measured: from baseline (pre-dose) to 24 hours after treatment administration
ECG - QTc interval
Electrocardiogram: QTc interval through Bazett's formula (ms)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: from baseline (pre-dose) to 24 hours after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start8 Jul 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pol Molina, PharmaD, Principal investigator, Institut de Recerca Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715163
- Sponsor's protocol ID
- DAO-MAX2024
- Acronym
- DAO-MAX2024
- Status last verified
- May 2025
- First submitted
- 19 Nov 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Safety and tolerability of the treatments will be evaluated by assessing vital signs, laboratory analyses, ECG and incidence of AE.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Tolerability of Three Doses of Diamine Oxidase (DAO) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06715163
- Acronym / sponsor ID
- DAO-MAX2024 / DAO-MAX2024
- Keywords
- safety, tolerability, diamino oxidase, DAO, supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AB BiotekIndustry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 (42mg) of DAO | Experimental | Dietary Supplement: Dose 1 (42mg) of DAOLowest dose of DAO administered in this study |
| Placebo tablets | Placebo comparator | Dietary Supplement: Placeboplacebo tablets |
| Dose 2 (84mg) of DAO | Experimental | Dietary Supplement: Dose 2 (84mg) of DAOMedium dose of DAO administered in this study |
| Dose 3 (210mg) of DAO | Experimental | Dietary Supplement: Dose 3 (210mg) of DAOHighest dose of DAO administered in this study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - 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.
Key exclusion criteria (13 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose 1 (42mg) of DAOAlso: diamino oxidase (DAO)DAO extract is obtained from pea sprout dehydrated powder. Lowest dose of DAO administered in this study | Dietary supplement | Dose 1 (42mg) of DAO |
| PlaceboContains the same excipients as the DAO tablets but without the diamino oxidase content | Dietary supplement | Placebo tablets |
| Dose 2 (84mg) of DAODAO extract is obtained from pea sprout dehydrated powder. Medium dose of DAO administered in this study | Dietary supplement | Dose 2 (84mg) of DAO |
| Dose 3 (210mg) of DAODAO extract is obtained from pea sprout dehydrated powder. Highest dose of DAO administered in this study | Dietary supplement | Dose 3 (210mg) of DAO |
Primary outcome
Vital signs - blood pressure
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Systolic blood pressure (mmHg) and Diastolic blood pressure (mmHg)
Vital signs - Heart Rate
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Heart rate as bpm (beats per minute)
Vital signs - Respiratory Rate
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Respiratory rate as bpm
Vital signs - temperature
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Body temperature as ºC (Celsius degrees)
ECG - Ventricular Rate (HR)
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: Ventricular rate (bpm)
ECG - PR interval
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: PR interval (ms)
ECG - QRS interval
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QRS interval (ms)
ECG - QT interval
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QT interval (ms)
ECG - QTc interval
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
Electrocardiogram: QTc interval through Bazett's formula (ms)
Laboratory analyses - Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
BIOCHEMISTRY: Concentrations of Glucose, Urea, Triglycerides, Cholesterol measured as mmol/L
Laboratory analyses - Concentrations of Creatinine, Total Bilirubin measured as micromol/L
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
BIOCHEMISTRY: Concentrations of Creatinine, Total Bilirubin measured as micromol/L
Laboratory analyses - 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
BIOCHEMISTRY: Concentrations of GOT (AST), GPT (ALT), GGT, Alkaline Phosphatase measured as U/L.
Laboratory analyses - Concentrations of Albumin, Haemoglobin, CCMH measured as g/L.
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
BIOCHEMISTRY: Concentrations of Albumin measured as g/L. HAEMATOLOGY: Concentrations of Haemoglobin, CCMH measured as g/L.
Laboratory analyses - Concentration of Haematocrit as L/L
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
HAEMATOLOGY: Concentration of Haematocrit as L/L
Laboratory analyses - 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
HAEMATOLOGY: Concentration of Platelet count, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes measured as x10E9/L.
Laboratory analyses
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
SEROLOGY: HIV, HBV and HCV measured through ELISA analysis as presence or absence (positive or negative result).
Laboratory analyses
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
SCREENING of DRUGS of ABUSE in URINE: ethanol, cannabis, amphetamines, cocaine, opiates and benzodiazepines measured as presence or absence (positive or negative result).
Incidence of adverse events
Time frame: from baseline (pre-dose) to 24 hours after treatment administration
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Yes. Safety and tolerability of the treatments will be evaluated by assessing vital signs, laboratory analyses, ECG and incidence of AE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pol Molina, PharmaD principal investigator
Institut de Recerca Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose 1 (42mg) of DAO, Dose 2 (84mg) of DAO and Dose 3 (210mg) of DAO in people with Safety and Tolerability in Healthy Volunteers, run by AB Biotek at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs - blood pressure (time frame: from baseline (pre-dose) to 24 hours after treatment administration). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.