Clinical trial NCT02288546: Vegans Health Status and Exposure to Pesticides and Nitrate
Official title: Vegans Exposure to Pesticides and Nitrate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Keywords: nutritional status
pesticides
nitrate
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
name: Helsinki University Central Hospital
name: Finnish Safety and Chemicals Agency
First posted: 2014-11-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vegans and non-vegans

Brief summary: This research concerns nutritional and toxicological health risk evaluation among long-term vegans. Research focus is in cumulative exposure to pesticides.

Detailed description: The main objective of the study was nutritional and toxicological health risk evaluation among long-term vegans with emphasis on cumulative exposure to pesticides. Main research methods include: measurement of food intake by using three days food record, measurement of nutritional and toxicological bio-markers on blood, serum and plasma. Nutritional biomarkers include following plasma/ serum measurements: concentrations of vitamins (vitamin E, D2, D3, B12 and beta-carotene), iron, iodine, selenium, fatty acids and polyphenols. Toxicological measurements include nitrate, pesticides and DNA-adducts.

We recruited the participants (n = 41) through an advertisement published in the Finnish Vegan Association's monthly newspaper and via an online discussion forum. The selection criteria were as follows: the participants had to (1) have followed a vegan diet for at least a year, (2) be between 18 and 50 years of age, (3) be apparently healthy, and (4) be nonusers of regular medications (except oral contraceptives or hormone replacement therapy). Further, we matched the non-vegetarian participants by age and sex. The study was approved by the Ethical Committee of Kuopio University Hospital (69//2011)

We assessed the consumption of foods at baseline with a three-day food record using household measures. The participants received the instructions on how to complete this record, and a dietician checked the completed food records. The participants also filled out a health questionnaire inquiring into their long-term healthy eating habits, including vitamin supplementation.

We collected fasting peripheral venous blood samples, plasma and serum, and stored them at -70 °C before the analysis. Further, urine samples 24 hours were collected prior to phlebotomy and divided into aliquots. For one of the subjects, only a spot urine sample was available. We carried out the hematological and chemical analyses at laboratory (hematological data), Helsinki University Central Hospital (folate, vitamin B12, vitamin D, and homocysteine), and the National Institute for Health and Welfare (alfa-tocopherol, beta-carotene, selenium, iodine, fatty acid profile, and polyphenols). Nitrate, nitrite were measured by capillary electrophoresis and DNA adducts by ELISA at Finnish Food Safety Authority.

Eligibility criteria: Inclusion Criteria:

The selection criteria were as follows: the participants had to

1. have followed a vegan diet for at least a year,
2. be between 18 and 50 years of age,
3. be apparently healthy, and
4. be nonusers of regular medications (except oral contraceptives or hormone replacement therapy). Further, we matched the non-vegetarian participants by age and sex.

Exclusion Criteria:

* age \<18, and \>50y,
* regular medication,
* illnesses

Primary outcomes:
measure: Nutritional and toxicological status (determined by measuring several nutritional biomarkers from blood and urine)
timeFrame: 1 year
Secondary outcomes:
measure: Food intake (recorded by 3-day records)
timeFrame: 3 days
measure: Nitrate excretion (urinary nitrate determination)
timeFrame: 24 hr
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland
name: Anna-Liisa Kosonen, PhD
role: PRINCIPAL_INVESTIGATOR
References: