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

July 27, 2016 updated by: Arne Astrup, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1984
        • IHE-LIFE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: II
organic animal manure
Other: Organic or conventional diet
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
Other: Diet (organic or conventional)
organic or conventional diet
Active Comparator: III
conventional
Other: Organic or conventional diet
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
Other: Diet (organic or conventional)
organic or conventional diet
Experimental: I
organic green manure
Other: Organic or conventional diet
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
Other: Diet (organic or conventional)
organic or conventional diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability of trace elements and secondary metabolites
Time Frame: 3 x 12 days
3 x 12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Health factors
Time Frame: 3 x 12 days
3 x 12 days

Other Outcome Measures

Outcome Measure
Time Frame
miRNA
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-C-2007-0078
  • M194

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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