- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02288546
Vegans Health Status and Exposure to Pesticides and Nitrate
Vegans Exposure to Pesticides and Nitrate
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Kuopio, Finland, 70211
- University of Eastern Finland
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Nutritional and toxicological status (determined by measuring several nutritional biomarkers from blood and urine)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Food intake (recorded by 3-day records)
Tijdsspanne: 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)
Tijdsspanne: 24 hr
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urinary nitrate determination
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24 hr
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anna-Liisa Kosonen, PhD, University of Eastern Finland
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UKuopio
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