HealthyOrgTraceNCT00738166
Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems
A study testing Organic or conventional diet and Diet (organic or conventional) in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Organic or conventional diet and Diet (organic or conventional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-45 years
- BMI 20-30 kg/m2
- Non-vegetarian
Who cannot join
- Physical activity > 10 h/week
- Intake of dietary supplements
- Regular use of drugs
- Chronic diseases
- Smoking
- Excessive intake of alcohol
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Organic or conventional diet, Diet (organic or conventional)
- Keywords
- diet, organic, health, healthy people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic or conventional dietOther
12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet
Diet (organic or conventional)Other
organic or conventional diet
| Study group | Role | What they receive |
|---|---|---|
| II | Experimental | organic animal manure Receives: Other: Organic or conventional diet; Other: Diet (organic or conventional) |
| III | Active comparator | conventional Receives: Other: Organic or conventional diet; Other: Diet (organic or conventional) |
| I | Experimental | organic green manure Receives: Other: Organic or conventional diet; Other: Diet (organic or conventional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of trace elements and secondary metabolites
Measured: 3 x 12 days
Secondary outcomes (1)
Health factors
Measured: 3 x 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738166
- Sponsor's protocol ID
- H-C-2007-0078
- Other IDs
- M194
- Acronym
- OrgTrace
- Status last verified
- Feb 2011
- First submitted
- 19 Aug 2008
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Content, Bioavailability and Health Effects of Trace Elements and Bioactive Components in Organic Agricultural Systems
- ClinicalTrials.gov ID
- NCT00738166
- Acronym / sponsor ID
- OrgTrace / H-C-2007-0078
- Conditions
- Healthy
- Keywords
- diet, organic, health, healthy people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| II | Experimental | Other: Organic or conventional diet, Other: Diet (organic or conventional)organic animal manure |
| III | Active comparator | Other: Organic or conventional diet, Other: Diet (organic or conventional)conventional |
| I | Experimental | Other: Organic or conventional diet, Other: Diet (organic or conventional)organic green manure |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18-45 years
- BMI 20-30 kg/m2
- Non-vegetarian
Key exclusion criteria (6 listed)
- Physical activity > 10 h/week
- Intake of dietary supplements
- Regular use of drugs
- Chronic diseases
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organic or conventional diet12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet | Other | I, II, III |
| Diet (organic or conventional)organic or conventional diet | Other | I, II, III |
Primary outcome
Bioavailability of trace elements and secondary metabolites
Time frame: 3 x 12 days
1 secondary outcome
Health factors
Time frame: 3 x 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic or conventional diet and Diet (organic or conventional) in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of trace elements and secondary metabolites (time frame: 3 x 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.