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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00738166
First received: August 19, 2008
Last updated: July 27, 2016
Last verified: February 2011
  Purpose
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.

Condition Intervention
Healthy
Other: Organic or conventional diet
Other: Diet (organic or conventional)

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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Bioavailability of trace elements and secondary metabolites [ Time Frame: 3 x 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health factors [ Time Frame: 3 x 12 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • miRNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738166

Locations
Denmark
IHE-LIFE
Frederiksberg, Denmark, 1984
Sponsors and Collaborators
University of Copenhagen
  More Information

Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00738166     History of Changes
Other Study ID Numbers: H-C-2007-0078  M194 
Study First Received: August 19, 2008
Last Updated: July 27, 2016
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
diet, organic, health
healthy people

ClinicalTrials.gov processed this record on December 09, 2016