Vegans Health Status and Exposure to Pesticides and Nitrate

Malnutrition Clinical Trial

Official title:

Vegans Exposure to Pesticides and Nitrate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288546
• Other study ID #: UKuopio
• Status: Completed
• Phase: Phase 0
• First received: November 3, 2014
• Last updated: November 6, 2014
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Advisory Board on Health Care EthicsFinland: Valvira - National Supervisory Authority for Welfare and HealthFinland: Finnish National Agency for Medicines
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malnutrition

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (4)

Lead Sponsor	Collaborator
University of Eastern Finland	Finnish Safety and Chemicals Agency, Helsinki University Central Hospital, National Institute for Health and Welfare, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional and toxicological status (determined by measuring several nutritional biomarkers from blood and urine)	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	1 year	Yes
Secondary	Food intake (recorded by 3-day records)	Food intake was recorded by 3-day records	3 days	Yes
Secondary	Nitrate excretion (urinary nitrate determination)	urinary nitrate determination	24 hr	Yes