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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02288546
Study type Observational
Source University of Eastern Finland
Contact
Status Completed
Phase Phase 0
Start date September 2011
Completion date November 2011

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