Assessing Toxic Metal Exposure From Vegetarian/Vegan, Omnivorous, and Low-carb Diets in Israel.

NCT07235332 | Enrolling By Invitation

• 1 other identifier: AU-HEA-AB-20240729
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring

Outcome Measures

Primary Outcomes (1)

• elevated toxic metal concentrations in blood, serum or urine

  At time of enrolment (single measurement during the recruitment visit, within 2 month of consent)

Study Arms (3)

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.

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.

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.

Behavioral: Screening

Interventions

Screening BEHAVIORAL

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

Plant based; low carb; omnivorous

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Ariel University

Ariel, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

morning spot urine, serum and whole blood samples will be retained for optional future studies

MeSH Terms

Interventions

Mass Screening

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: November 19, 2025
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

IL (1)