Effect of Mediterranean Diets Based on Organic and Conventional Foods

Health Status Clinical Trial

Official title:

Effect of Mediterranean Diets Based on Organic and Conventional Foods on Health Related Physiological Parameters in Urine and Blood/Plasma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03254537
• Other study ID #: NUHEALTH-CS01-ORGANIC
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 21, 2017
• Last updated: August 17, 2017
• Start date: May 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 27
• Est. completion date: December 31, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Status

Intervention

Dietary Supplement:
• Mediterranean Organic
Traditional Mediterranean diet comprised of organic ingredients
• Mediterranean conventional
Traditional Mediterranean diet comprised of conventional ingredients

Locations

Country	Name	City	State
Greece	Levidopa Field Station	Sivas	Sivas Festos
United Kingdom	NU-Food Research Facility	Newcastle upon Tyne	Tyne and Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle University	The Sheepdrove Trust

Countries where clinical trial is conducted

Greece,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-6 in Plasma measured using ELISA		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	IL-6 in WBC measured using ELISA		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	DNA damage in WBC measured using Western Blot		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	Total antioxidant activity in plasma measured using PENTRA		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	Phenols in plasma measured using GCMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	Carotenoids in plasma measured using GCMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	Pesticides in urine and plasma measured using ICPMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	Isoprostanes in urine measured using ICPMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	toxic metals in urine and plasma (Cd, Pb, Hg, Al) measured using ICPMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Primary	minerals in plasma (including Cu, Fe, Mn, Mg, Ca, I, Se) measured using ICPMS		Change from baseline 2 weeks post supplementation and 4 weeks post supplementation