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Effect of Mediterranean Diets Based on Organic and Conventional Foods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03254537
Recruitment Status : Unknown
Verified August 2017 by Newcastle University.
Recruitment status was:  Enrolling by invitation
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
The Sheepdrove Trust
Information provided by (Responsible Party):
Newcastle University

Brief Summary:

Results from a small number of human cohort studies are also available and indicate that there are positive associations between organic food consumption and reduced risk/incidence of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity/overweight.

Results from animal dietary intervention studies suggest that (i) switching to organic food consumption results in significant changes in hormonal balances and an increase in immune system responsiveness and (ii) differences in pesticide residue, cadmium, protein and antioxidant concentrations between organic and conventional foods are major drivers for hormonal balances and immune system parameters in animals.

However, there is virtually no published data from (i) long-term cohort studies focusing on chronic diseases (e.g. cardiovascular disease, diabetes, cancer and neurodegenerative conditions) and (ii) controlled human dietary intervention studies comparing effects of organic and conventional diets. It is therefore currently not possible to assess whether and estimate to what extent organic food consumption may affect human health.


Condition or disease Intervention/treatment Phase
Health Status Dietary Supplement: Mediterranean Organic Dietary Supplement: Mediterranean conventional Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 1, 2017
Estimated Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Mediterranean Organic Dietary Supplement: Mediterranean Organic
Traditional Mediterranean diet comprised of organic ingredients

Experimental: Mediterranean conventional Dietary Supplement: Mediterranean conventional
Traditional Mediterranean diet comprised of conventional ingredients




Primary Outcome Measures :
  1. IL-6 in Plasma measured using ELISA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  2. IL-6 in WBC measured using ELISA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  3. DNA damage in WBC measured using Western Blot [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  4. Total antioxidant activity in plasma measured using PENTRA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  5. Phenols in plasma measured using GCMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  6. Carotenoids in plasma measured using GCMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  7. Pesticides in urine and plasma measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  8. Isoprostanes in urine measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  9. toxic metals in urine and plasma (Cd, Pb, Hg, Al) measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  10. minerals in plasma (including Cu, Fe, Mn, Mg, Ca, I, Se) measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adults No medications No known illness

Exclusion Criteria:

Any known illness Using prescribed medication Using over the counter vitamin or mineral supplements Allergy to any food


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254537


Locations
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Greece
Levidopa Field Station
Sivas, Sivas Festos, Greece, GR 70200
United Kingdom
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
Sponsors and Collaborators
Newcastle University
The Sheepdrove Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Newcastle University
ClinicalTrials.gov Identifier: NCT03254537    
Other Study ID Numbers: NUHEALTH-CS01-ORGANIC
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No