Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems

Healthy Clinical Trial

— OrgTrace  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738166
• Other study ID #: H-C-2007-0078
• Secondary ID: M194
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: July 27, 2016
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Trace elements, bioactive secondary metabolites and vitamins are among the most important quality parameters in plants. Yet, very little information is available on their content, bioavailability and health effects of organically grown plant food products. The main objective of the project is to study the impact of different agricultural management practises relevant for organic farming on the ability of cereal and vegetable crops to absorb trace elements from the soil and to synthesise bioactive compounds (secondary metabolites, antioxidant vitamins and phytates) with health promoting effects. Field experiments with a rigidly controlled design will be implemented together with state-of-the-art analytical techniques allowing solid conclusions to be drawn on the variability and optimum levels of bioactive compounds. The multitude of analytical data from plant and soil samples will be analysed by multivariate statistical methods in order to reveal differences between the cultivation systems used. Finally, the relationship between bioavailability of the nutrients studied and the elemental fingerprint of plants will be extracted by the statistical methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged 18-45 years

• BMI 20-30 kg/m2

• Non-vegetarian

Exclusion Criteria:

• Physical activity > 10 h/week

• Intake of dietary supplements

• Regular use of drugs

• Chronic diseases

• Smoking

• Excessive intake of alcohol

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Organic or conventional diet
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
• Diet (organic or conventional)
organic or conventional diet

Locations

Country	Name	City	State
Denmark	IHE-LIFE	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	miRNA		1 year	No
Primary	Bioavailability of trace elements and secondary metabolites		3 x 12 days	No
Secondary	Health factors		3 x 12 days	No