NCT00738166

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 29, 2016

Status Verified

February 1, 2011

Enrollment Period

2.3 years

First QC Date

August 19, 2008

Last Update Submit

July 27, 2016

Conditions

Keywords

diet, organic, healthhealthy people

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of trace elements and secondary metabolites

    3 x 12 days

Secondary Outcomes (1)

  • Health factors

    3 x 12 days

Other Outcomes (1)

  • miRNA

    1 year

Study Arms (3)

II

EXPERIMENTAL

organic animal manure

Other: Organic or conventional dietOther: Diet (organic or conventional)

III

ACTIVE COMPARATOR

conventional

Other: Organic or conventional dietOther: Diet (organic or conventional)

I

EXPERIMENTAL

organic green manure

Other: Organic or conventional dietOther: Diet (organic or conventional)

Interventions

12 days on fully controlled organic 1 diet, organic 2 diet and conventional diet

IIIIII

organic or conventional diet

IIIIII

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18-45 years
  • BMI 20-30 kg/m2
  • Non-vegetarian

You may not qualify if:

  • Physical activity \> 10 h/week
  • Intake of dietary supplements
  • Regular use of drugs
  • Chronic diseases
  • Smoking
  • Excessive intake of alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IHE-LIFE

Frederiksberg, 1984, Denmark

Location

MeSH Terms

Interventions

DietCongresses as Topic

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaOrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

October 1, 2007

Primary Completion

January 1, 2010

Study Completion

December 1, 2010

Last Updated

July 29, 2016

Record last verified: 2011-02

Locations