Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human BiomonitoringNCT07235332
Assessing Toxic Metal Exposure From Vegetarian/Vegan, Omnivorous, and Low-carb Diets in Israel.
An observational study of Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Different dietary intake may pose various health risks as as these have different potential exposure to heavy metals, which may originate from soils, irrigation systems, infrastructure, packaging, and other environmental exposures to toxic metals such as livestock nutritional intake. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring
- What is being tested?
- Screening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We will initiate participant recruitment through social media outreach, targeting students from Ariel University as well as other academic institutes and areas located nearby Ariel University (the operating institution of the study). Eligible participants who will sign informed consent include young adults (20-45 years), identifying as vegetarians/vegans ("plantbased diet"; aim for 20% vegans), omnivores ("regular diet"), or low-carbohydrate diet followers ("animal-based diet" such as paleo, ketogenic diets, etc.) and following these diets for a minimum of one year (the statement on the personal diet pattern will be verified by using by a validated food frequency questionnaire [FFQ]) developed by the Israeli Ministry of Health, Department of Nutrition (adapted from (Berman et al., 2023).
Who may be able to join
- Adults aged 20 to 49 years
- Generally healthy
- Following a specific diet (vegetarian/vegan, low-carbohydrate, or omnivorous) for at least one year
- Completion of all required screenings, including questionnaires, blood tests, morning urine sample, BIA, and DXA
Who cannot join
- Pregnancy
- Chronic illness or history of cancer
- High risk of heavy metal exposure (based on occupational data)
- Age outside 20 to 49 years
- Body mass index (BMI) greater than 40 kg/m²
- Incomplete data submission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Exposure to Toxic Metals in Relation to Different Diet Patterns - the DietBiom CALC-M Study: Dietary Biomonitoring of Cadmium, Arsenic, Lead, Chromium, and Mercury
Different dietary intake may pose various health risks as as these have different potential exposure to heavy metals, which may originate from soils, irrigation systems, infrastructure, packaging, and other environmental exposures to toxic metals such as livestock nutritional intake. In this study, we aim to quantify toxic metals such as cadmium, lead, chromium, arsenic, and mercury, as well as macro and micronutrient contents in humans that are under three different diets (vegetarian-vegan, omnivorous, and low-carbohydrate diets). Short- and long-term nutritional intake will be obtained using food diaries and validated food frequency questionnaire, respectively. Analysis of essential nutrients as well as toxic metals will be assessed from nutritional software and database. Samples of blood (whole blood and serum) and urine as well as sub-samples of several common food items from 250 healthy volunteers will be collected and analyzed using standardized chemical protocol and quantified by an ICP-MS. Through the chemical results we intend to correlate dietary patterns with heavy metal exposure and identify diet-related exposure risks. These correlations will help in informing professionals and the public and will improve public health recommendations. This initiative stands out in its focus on a comprehensive dietary assessment to understand the impact of different dietary choices on metal exposure levels, particularly in the Israeli context.
Read the detailed description
Detailed Study Description Sampling, Eligibility Criteria, and Sample Size
Participant recruitment will be initiated through social media campaigns targeting students from Ariel University and nearby academic institutions. Eligible participants will be healthy adults aged 20-45 years who have adhered for at least one year to one of three self-identified dietary patterns:
Plant-based diet (vegetarian or vegan; target 20% vegans),
Omnivorous diet ("regular" mixed diet), or
Low-carbohydrate diet (animal-based dietary patterns such as paleo or ketogenic).
Dietary pattern will be verified using a validated Food Frequency Questionnaire (FFQ) developed by the Israeli Ministry of Health, Department of Nutrition (adapted from Berman et al., 2023).
Exclusion criteria include obesity (BMI ≥ 30 kg/m²), underweight (BMI ≤ 18.5 kg/m²), or any chronic disease, verified via self-report and confirmed by a physician's medical summary.
Following informed consent, participants will complete the FFQ through the NutRatio® dietary-analysis software to confirm diet pattern. A brief phone interview and an instructional video will orient participants to study procedures and eligibility requirements.
We aim to recruit 250 participants in total, evenly distributed across the three diet groups. Participants will be frequency-matched by age (± 5 years), BMI (± 3 kg/m²), and smoking status, given smoking's established association with metal exposure. Sample size is based on ANOVA (Cohen's f = 0.25, medium effect size).
Measurement Day Protocol
Eligible participants will be scheduled for a standardized assessment session (~2 hours) at the MetaboLab, Department of Nutritional Sciences, Ariel University.
Short-term dietary intake: Participants will complete a 3-day food record (two weekdays + one weekend day) using NutRatio software within two weeks before their visit. The tool integrates USDA (SR-28), Israeli Ministry of Health (2017), and updated food label databases (2024). Participants will photograph each meal before and after eating, upload photos to the research team, and record foods immediately after consumption. The team will review entries daily, ensuring completeness and logical accuracy; missing or unclear data will be clarified by phone the next day.
NutRatio will quantify energy, macronutrients (including fatty-acid and amino-acid profiles), dietary fiber, selected vitamins (e.g., folate, B-12), and minerals (e.g., calcium, iron, zinc). Dietary metal exposure will be estimated from the reported foods using both NutRatio and additional reference databases. These values will later be compared to international toxicological thresholds (e.g., U.S. CDC, German Environment Agency).
Food Sampling for Toxic Metal Assessment
Based on correlations between reported intake and measured blood or urine metal levels, food groups most associated with each metal will be identified. Representative items will then be sampled for laboratory analysis.
For example, if mercury levels correlate strongly with fish intake, approximately six fish species or brands most commonly consumed by high-exposure participants will be purchased and analyzed. The type and brand of food will be confirmed through participant follow-up when necessary.
Each food item will undergo chemical digestion and quantification of metals (cadmium, lead, chromium, arsenic, mercury). Measured concentrations will be compared with international datasets including EFSA, Codex Alimentarius, U.S. NCEH, and the Israeli Ministry of Health (Food Control Services, 2016).
Anthropometric and Demographic Measures
Participants will attend the study visit after an overnight fast (water only). Measurements will include:
Weight and height (standardized protocols),
Body composition using InBody 570 (Biospace, Korea), a validated bioelectrical impedance analyzer providing body-fat, muscle-mass, and water-compartment data (Miller et al., 2016; Sirirat et al., 2020).
Questionnaires will collect demographic information, health history, smoking, occupational exposures (including military service), and lifestyle factors related to environmental pollutant exposure. These tools are adapted from Israel's national heavy-metal survey (Berman et al., 2023) and the European PARC initiative (https://www.eu-parc.eu
).
Biological Sample Collection and Chemical Analysis
Blood (whole and serum) and urine samples will be collected using BPA-free tubes and stored at -20 °C until analysis to prevent chemical degradation. Serum will be separated by controlled thawing (2-8 °C overnight), gentle mixing, clotting (30 min), centrifugation (15 min, 2000 rpm), and pipette aspiration. Whole-blood samples will be homogenized by vortex.
Samples (blood, serum, urine, and food) will be digested using analytical-grade nitric acid and hydrogen peroxide in a microwave digestion system following EPA 3052 protocols (Bocca et al., 2003). Blank samples will accompany each batch to determine limits of detection and quantification. Quality control will include certified reference materials and inter-laboratory validation using split samples.
Primary analyses will be conducted at Ariel University's Trace Metal Laboratory (Co-PI: Dr. Daniel Palchan). Additional or confirmatory analyses may occur at the Ministry of Health laboratory (Dr. Tamar Berman), Hebrew University, Weizmann Institute, or Geological Survey of Israel, depending on instrument availability.
Trace-element quantification will be performed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) according to validated methods (Laur et al., 2020). Analytical protocols will align with CDC DLS 3040.1-01. Metal concentrations in blood and urine will be compared with reference values from national (Berman et al., 2023) and international surveys (CDC 2018; EFSA 2010; German Environment Agency 2023).
Results will be evaluated against Human Biomonitoring (HBM-I, HBM-II) thresholds (German Environment Agency 2023). Creatinine will be measured for urinary normalization.
Data Integration and Statistical Analysis
All data sources-FFQ, 3-day food record, anthropometric measures, biological samples, and chemical analyses-will be integrated into a unified database. Statistical analyses will examine relationships between dietary pattern and biomarker concentrations using ANOVA, multivariable regression, and correlation analyses. Dietary estimates of metal exposure will be compared with both measured biological levels and concentrations found in representative food samples.
Potential confounders (age, BMI, smoking, and occupational exposure) will be adjusted for in multivariate models. Sensitivity analyses will explore differences by sex and by vegan versus vegetarian subgroups within the plant-based group.
Pilot Study
A pilot phase involving 10 volunteers will precede full data collection. The pilot will test recruitment, informed-consent communication, FFQ completion, anthropometric assessment, biospecimen collection, and data-entry logistics. It will also be used to optimize sample-preparation protocols in the Trace Metal Laboratory.
If full analytical workflows cannot yet be implemented, mock data for metal levels will be generated to validate database structure and preliminary statistical pipelines. Biological samples from the pilot will be stored frozen for later analysis once full ICP-MS procedures are operational.
- Being tested
- Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningBehavioural
no intervention. Just data collection in a cross-sectional study manner. We will collect blood and urine and preform BIA and DXA and also make them fill questioners
| Study group | Role | What they receive |
|---|---|---|
| omnivorous | Healthy adults aged 20-49 years who consume a regular mixed diet including both plant and animal foods. Participants must have maintained this diet pattern for ≥ 1 year prior to enrollment. Exclusion criteria include class 3 obesity (BMI ≥ 09.9 kg/m²), or any chronic illness. Participants will complete dietary questionnaires and provide biological samples for assessment of toxic-metal exposure and nutritional biomarkers. Receives: Behavioral: Screening | |
| low carb | Healthy adults aged 20-49 years adhering for ≥ 1 year to a carbohydrate-restricted or animal-based diet, such as ketogenic, paleo, or carnivore-style patterns. Diets emphasize animal-derived foods and limit carbohydrate intake. Eligible participants have BMI 18.5-39.9 kg/m² and no chronic medical conditions. Group will undergo identical dietary, anthropometric, and biological assessments to quantify toxic-metal exposure and nutritional-status indicators. Receives: Behavioral: Screening | |
| Plant based | Healthy adults aged 20-49 years who have followed a vegetarian or vegan diet for ≥ 1 year. Participants consume no meat, poultry, or fish; vegans avoid all animal products. The target composition is about 20 % vegans within the plant-based group. BMI 18.5-39.9 kg/m², and free of chronic disease. Participants will provide dietary data (FFQ + 3-day food record), anthropometric measurements, and biological samples for toxic-metal and nutritional-status assessment. Receives: Behavioral: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
elevated toxic metal concentrations in blood, serum or urine
Measured: At time of enrolment (single measurement during the recruitment visit, within 2 month of consent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Aug 2025
- Primary completion30 Oct 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human BiomonitoringStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235332
- Sponsor's protocol ID
- AU-HEA-AB-20240729
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Exposure to Toxic Metals in Relation to Different Diet Patterns - the DietBiom CALC-M Study: Dietary Biomonitoring of Cadmium, Arsenic, Lead, Chromium, and Mercury
- ClinicalTrials.gov ID
- NCT07235332
- Acronym / sponsor ID
- AU-HEA-AB-20240729
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Nov 2025 (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.
Different dietary intake may pose various health risks as as these have different potential exposure to heavy metals, which may originate from soils, irrigation systems, infrastructure, packaging, and other environmental exposures to toxic metals such as livestock nutritional intake. In this study, we aim to quantify toxic metals such as cadmium, lead, chromium, arsenic, and mercury, as well as macro and micronutrient contents in humans that are under three different diets (vegetarian-vegan, omnivorous, and low-carbohydrate diets). Short- and long-term nutritional intake will be obtained using food diaries and validated food frequency questionnaire, respectively. Analysis of essential nutrients as well as toxic metals will be assessed from nutritional software and database. Samples of blood (whole blood and serum) and urine as well as sub-samples of several common food items from 250 healthy volunteers will be collected and analyzed using standardized chemical protocol and quantified by an ICP-MS. Through the chemical results we intend to correlate dietary patterns with heavy metal exposure and identify diet-related exposure risks. These correlations will help in informing professionals and the public and will improve public health recommendations. This initiative stands out in its focus on a comprehensive dietary assessment to understand the impact of different dietary choices on metal exposure levels, particularly in the Israeli context.
Detailed description
Detailed Study Description Sampling, Eligibility Criteria, and Sample Size
Participant recruitment will be initiated through social media campaigns targeting students from Ariel University and nearby academic institutions. Eligible participants will be healthy adults aged 20-45 years who have adhered for at least one year to one of three self-identified dietary patterns:
Plant-based diet (vegetarian or vegan; target 20% vegans),
Omnivorous diet ("regular" mixed diet), or
Low-carbohydrate diet (animal-based dietary patterns such as paleo or ketogenic).
Dietary pattern will be verified using a validated Food Frequency Questionnaire (FFQ) developed by the Israeli Ministry of Health, Department of Nutrition (adapted from Berman et al., 2023).
Exclusion criteria include obesity (BMI ≥ 30 kg/m²), underweight (BMI ≤ 18.5 kg/m²), or any chronic disease, verified via self-report and confirmed by a physician's medical summary.
Following informed consent, participants will complete the FFQ through the NutRatio® dietary-analysis software to confirm diet pattern. A brief phone interview and an instructional video will orient participants to study procedures and eligibility requirements.
We aim to recruit 250 participants in total, evenly distributed across the three diet groups. Participants will be frequency-matched by age (± 5 years), BMI (± 3 kg/m²), and smoking status, given smoking's established association with metal exposure. Sample size is based on ANOVA (Cohen's f = 0.25, medium effect size).
Measurement Day Protocol
Eligible participants will be scheduled for a standardized assessment session (~2 hours) at the MetaboLab, Department of Nutritional Sciences, Ariel University.
Short-term dietary intake: Participants will complete a 3-day food record (two weekdays + one weekend day) using NutRatio software within two weeks before their visit. The tool integrates USDA (SR-28), Israeli Ministry of Health (2017), and updated food label databases (2024). Participants will photograph each meal before and after eating, upload photos to the research team, and record foods immediately after consumption. The team will review entries daily, ensuring completeness and logical accuracy; missing or unclear data will be clarified by phone the next day.
NutRatio will quantify energy, macronutrients (including fatty-acid and amino-acid profiles), dietary fiber, selected vitamins (e.g., folate, B-12), and minerals (e.g., calcium, iron, zinc). Dietary metal exposure will be estimated from the reported foods using both NutRatio and additional reference databases. These values will later be compared to international toxicological thresholds (e.g., U.S. CDC, German Environment Agency).
Food Sampling for Toxic Metal Assessment
Based on correlations between reported intake and measured blood or urine metal levels, food groups most associated with each metal will be identified. Representative items will then be sampled for laboratory analysis.
For example, if mercury levels correlate strongly with fish intake, approximately six fish species or brands most commonly consumed by high-exposure participants will be purchased and analyzed. The type and brand of food will be confirmed through participant follow-up when necessary.
Each food item will undergo chemical digestion and quantification of metals (cadmium, lead, chromium, arsenic, mercury). Measured concentrations will be compared with international datasets including EFSA, Codex Alimentarius, U.S. NCEH, and the Israeli Ministry of Health (Food Control Services, 2016).
Anthropometric and Demographic Measures
Participants will attend the study visit after an overnight fast (water only). Measurements will include:
Weight and height (standardized protocols),
Body composition using InBody 570 (Biospace, Korea), a validated bioelectrical impedance analyzer providing body-fat, muscle-mass, and water-compartment data (Miller et al., 2016; Sirirat et al., 2020).
Questionnaires will collect demographic information, health history, smoking, occupational exposures (including military service), and lifestyle factors related to environmental pollutant exposure. These tools are adapted from Israel's national heavy-metal survey (Berman et al., 2023) and the European PARC initiative (https://www.eu-parc.eu
).
Biological Sample Collection and Chemical Analysis
Blood (whole and serum) and urine samples will be collected using BPA-free tubes and stored at -20 °C until analysis to prevent chemical degradation. Serum will be separated by controlled thawing (2-8 °C overnight), gentle mixing, clotting (30 min), centrifugation (15 min, 2000 rpm), and pipette aspiration. Whole-blood samples will be homogenized by vortex.
Samples (blood, serum, urine, and food) will be digested using analytical-grade nitric acid and hydrogen peroxide in a microwave digestion system following EPA 3052 protocols (Bocca et al., 2003). Blank samples will accompany each batch to determine limits of detection and quantification. Quality control will include certified reference materials and inter-laboratory validation using split samples.
Primary analyses will be conducted at Ariel University's Trace Metal Laboratory (Co-PI: Dr. Daniel Palchan). Additional or confirmatory analyses may occur at the Ministry of Health laboratory (Dr. Tamar Berman), Hebrew University, Weizmann Institute, or Geological Survey of Israel, depending on instrument availability.
Trace-element quantification will be performed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) according to validated methods (Laur et al., 2020). Analytical protocols will align with CDC DLS 3040.1-01. Metal concentrations in blood and urine will be compared with reference values from national (Berman et al., 2023) and international surveys (CDC 2018; EFSA 2010; German Environment Agency 2023).
Results will be evaluated against Human Biomonitoring (HBM-I, HBM-II) thresholds (German Environment Agency 2023). Creatinine will be measured for urinary normalization.
Data Integration and Statistical Analysis
All data sources-FFQ, 3-day food record, anthropometric measures, biological samples, and chemical analyses-will be integrated into a unified database. Statistical analyses will examine relationships between dietary pattern and biomarker concentrations using ANOVA, multivariable regression, and correlation analyses. Dietary estimates of metal exposure will be compared with both measured biological levels and concentrations found in representative food samples.
Potential confounders (age, BMI, smoking, and occupational exposure) will be adjusted for in multivariate models. Sensitivity analyses will explore differences by sex and by vegan versus vegetarian subgroups within the plant-based group.
Pilot Study
A pilot phase involving 10 volunteers will precede full data collection. The pilot will test recruitment, informed-consent communication, FFQ completion, anthropometric assessment, biospecimen collection, and data-entry logistics. It will also be used to optimize sample-preparation protocols in the Trace Metal Laboratory.
If full analytical workflows cannot yet be implemented, mock data for metal levels will be generated to validate database structure and preliminary statistical pipelines. Biological samples from the pilot will be stored frozen for later analysis once full ICP-MS procedures are operational.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| omnivorous | – | Behavioral: ScreeningHealthy adults aged 20-49 years who consume a regular mixed diet including both plant and animal foods. Participants must have maintained this diet pattern for ≥ 1 year prior to enrollment. Exclusion criteria include class 3 obesity (BMI ≥ 09.9 kg/m²), or any chronic illness. Participants will complete dietary questionnaires and provide biological samples for assessment of toxic-metal exposure and nutritional biomarkers. |
| low carb | – | Behavioral: ScreeningHealthy adults aged 20-49 years adhering for ≥ 1 year to a carbohydrate-restricted or animal-based diet, such as ketogenic, paleo, or carnivore-style patterns. Diets emphasize animal-derived foods and limit carbohydrate intake. Eligible participants have BMI 18.5-39.9 kg/m² and no chronic medical conditions. Group will undergo identical dietary, anthropometric, and biological assessments to quantify toxic-metal exposure and nutritional-status indicators. |
| Plant based | – | Behavioral: ScreeningHealthy adults aged 20-49 years who have followed a vegetarian or vegan diet for ≥ 1 year. Participants consume no meat, poultry, or fish; vegans avoid all animal products. The target composition is about 20 % vegans within the plant-based group. BMI 18.5-39.9 kg/m², and free of chronic disease. Participants will provide dietary data (FFQ + 3-day food record), anthropometric measurements, and biological samples for toxic-metal and nutritional-status assessment. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will initiate participant recruitment through social media outreach, targeting students from Ariel University as well as other academic institutes and areas located nearby Ariel University (the operating institution of the study). Eligible participants who will sign informed consent include young adults (20-45 years), identifying as vegetarians/vegans ("plantbased diet"; aim for 20% vegans), omnivores ("regular diet"), or low-carbohydrate diet followers ("animal-based diet" such as paleo, ketogenic diets, etc.) and following these diets for a minimum of one year (the statement on the personal diet pattern will be verified by using by a validated food frequency questionnaire [FFQ]) developed by the Israeli Ministry of Health, Department of Nutrition (adapted from (Berman et al., 2023).
Key inclusion criteria (4 listed)
- Adults aged 20 to 49 years
- Generally healthy
- Following a specific diet (vegetarian/vegan, low-carbohydrate, or omnivorous) for at least one year
- Completion of all required screenings, including questionnaires, blood tests, morning urine sample, BIA, and DXA
Key exclusion criteria (6 listed)
- Pregnancy
- Chronic illness or history of cancer
- High risk of heavy metal exposure (based on occupational data)
- Age outside 20 to 49 years
- Body mass index (BMI) greater than 40 kg/m²
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 |
|---|---|---|
| Screeningno intervention. Just data collection in a cross-sectional study manner. We will collect blood and urine and preform BIA and DXA and also make them fill questioners | Behavioural | Plant based, low carb, omnivorous |
Primary outcome
elevated toxic metal concentrations in blood, serum or urine
Time frame: At time of enrolment (single measurement during the recruitment visit, within 2 month of consent)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 19 Nov 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 Israel. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
elevated toxic metal concentrations in blood, serum or urine (time frame: At time of enrolment (single measurement during the recruitment visit, within 2 month of consent)). 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 19 Nov 2025.