- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00738166
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
-
-
-
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
|
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
organic or conventional diet
|
|
Active Comparator: III
conventional
|
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
organic or conventional diet
|
|
Experimental: I
organic green manure
|
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
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
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.