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Vegans Health Status and Exposure to Pesticides and Nitrate

NCT ID: NCT02288546

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Malnutrition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Vegans

Vegans' data are compared with those of sex-and age-matched non vegetarians

No interventions assigned to this group

Non-vegans

Non-vegans are age and sex-matched controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Finnish Safety and Chemicals Agency

UNKNOWN

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna-Liisa Kosonen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland

Kuopio, Finland, Finland

Site Status

Countries

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Finland

Other Identifiers

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UKuopio

Identifier Type: -

Identifier Source: org_study_id