- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02288546
Vegans Health Status and Exposure to Pesticides and Nitrate
Vegans Exposure to Pesticides and Nitrate
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Kuopio, Finland, 70211
- University of Eastern Finland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
The selection criteria were as follows: the participants had to
- have followed a vegan diet for at least a year,
- be between 18 and 50 years of age,
- be apparently healthy, and
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Vegans
Vegans' data are compared with those of sex-and age-matched non vegetarians
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Non-vegans
Non-vegans are age and sex-matched controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional and toxicological status (determined by measuring several nutritional biomarkers from blood and urine)
Time Frame: 1 year
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Nutritional status was determined by measuring several nutritional biomarkers (vitamin E, D2,D3, B12, , beta-carotene, iron, iodine, selenium, fatty acids, polyphenols) from serum/plasma or urine
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food intake (recorded by 3-day records)
Time Frame: 3 days
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Food intake was recorded by 3-day records
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3 days
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Nitrate excretion (urinary nitrate determination)
Time Frame: 24 hr
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urinary nitrate determination
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24 hr
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna-Liisa Kosonen, PhD, University of Eastern Finland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKuopio
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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