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History of Changes for Study: NCT03254537
Effect of Mediterranean Diets Based on Organic and Conventional Foods
Latest version (submitted August 17, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 17, 2017 None (earliest Version on record)
Comparison Format:

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Study NCT03254537
Submitted Date:  August 17, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: NUHEALTH-CS01-ORGANIC
Brief Title: Effect of Mediterranean Diets Based on Organic and Conventional Foods
Official Title: Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2017
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: May 1, 2017
Primary Completion: August 1, 2017 [Actual]
Study Completion: December 31, 2017 [Anticipated]
First Submitted: June 21, 2017
First Submitted that
Met QC Criteria:
August 17, 2017
First Posted: August 18, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
August 17, 2017
Last Update Posted: August 18, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Newcastle University
Responsible Party: Sponsor
Collaborators: The Sheepdrove Trust
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Detailed Description:

The most recent systematic literature reviews and meta-analyses have indicated significant and nutritionally-relevant composition differences between organic and conventional foods (crops, meat and dairy products). Specifically, these systematic reviews reported that:

organic crops have 17% higher antioxidant activity and between 18% and 69% higher concentrations of a range of individual antioxidants; increased intakes of polyphenolics and antioxidants has been linked to a reduced risk of certain chronic diseases such as cardiovascular and neurodegenerative diseases and certain cancers.

conventional crops have 48% higher levels of the toxic metal cadmium, and are 4-times more likely to contain detectable pesticide residues; there are general recommendations to minimise the intake of pesticides and cadmium to avoid potential negative health impacts.

conventional crops also have 15%, 10%, 30%, and 87% higher concentrations of protein, nitrogen, nitrate, nitrite, respectively; increased intakes of these compounds have been linked to both positive and negative health impacts.

organic meat, milk and dairy products have approximately 50% higher concentrations of nutritionally-desirable omega-3 fatty acids; intakes of very long chain omega-3 fatty acids in Western diets and there are EFSA recommendation to at least double their intake.

organic milk has 70% lower concentrations of iodine and slightly lower concentrations of Selenium, which is nutritionally undesirables especially in the UK where (a) the Se content of cereals has decreased (due to reduced import of cereals grown on Se-rich soil (b) Iodine fortified table salt is not widely available and used and the iodine supply relies more on mineral fortification of animal, and especially dairy feeds.

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.

The overall aim of the study is to get a quantitative understanding of (a) the uptake (and therefore potential to affect health) of food composition components (pesticide residues, toxic metals such as cadmium, antioxidants) that differ between organic and conventional foods and (b) the effect of organic vs conventional food consumption on selected physiological parameters in plasma linked to health.

This information will be essential to (a) carry out accurate statistical power analyses (based on uptake [=estimated from blood and urine concentrations] rather than food composition data) and (b) optimise designs for longer-term dietary intervention studies, designed to identify impacts of organic food consumption on health related physiological markers in humans and mechanisms for potential health impacts.

The main objectives of the proposed study are to:

  1. Carry out a human dietary intervention study comparing the effects of switching to Mediterranean diets based on organic and conventional foods on concentrations of pesticides, toxic metals, mineral nutrients (e.g. Fe, Cu, Se, I) and antioxidants, and antioxidant activity and selected health-related markers in urine and blood.
  2. Quantify concentrations of pesticide residue, mineral, toxic metal and antioxidants in both organic and conventional food samples consumed during the intervention period
  3. Carry out both univariate and redundancy analyses to both quantify effects of different diets on urine and blood composition and to identify the most important food composition drivers for differences in urine/blood composition and health markers.
Open or close this module Conditions
Conditions: Health Status
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 27 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 40 Years
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Locations: Greece, Sivas Festos
Levidopa Field Station
Sivas, Sivas Festos, Greece, GR 70200
United Kingdom, Tyne and Wear
NU-Food Research Facility
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services