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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

Tracking Information
First Submitted Date  ICMJE June 21, 2017
First Posted Date  ICMJE August 18, 2017
Last Update Posted Date August 18, 2017
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2017)
  • IL-6 in Plasma measured using ELISA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • IL-6 in WBC measured using ELISA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • DNA damage in WBC measured using Western Blot [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • Total antioxidant activity in plasma measured using PENTRA [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • Phenols in plasma measured using GCMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • Carotenoids in plasma measured using GCMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • Pesticides in urine and plasma measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • Isoprostanes in urine measured using ICPMS [ Time Frame: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mediterranean Diets Based on Organic and Conventional Foods
Official Title  ICMJE Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Health Status
Intervention  ICMJE
  • Dietary Supplement: Mediterranean Organic
    Traditional Mediterranean diet comprised of organic ingredients
  • Dietary Supplement: Mediterranean conventional
    Traditional Mediterranean diet comprised of conventional ingredients
Study Arms  ICMJE
  • Experimental: Mediterranean Organic
    Intervention: Dietary Supplement: Mediterranean Organic
  • Experimental: Mediterranean conventional
    Intervention: Dietary Supplement: Mediterranean conventional
Publications * Rempelos L, Wang J, Barański M, Watson A, Volakakis N, Hoppe HW, Kühn-Velten WN, Hadall C, Hasanaliyeva G, Chatzidimitriou E, Magistrali A, Davis H, Vigar V, Średnicka-Tober D, Rushton S, Iversen PO, Seal CJ, Leifert C. Diet and food type affect urinary pesticide residue excretion profiles in healthy individuals: results of a randomized controlled dietary intervention trial. Am J Clin Nutr. 2022 Feb 9;115(2):364-377. doi: 10.1093/ajcn/nqab308.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 17, 2017)		 27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03254537
Other Study ID Numbers  ICMJE NUHEALTH-CS01-ORGANIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Newcastle University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Newcastle University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Sheepdrove Trust
Investigators  ICMJE Not Provided
PRS Account Newcastle University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP