Effect of Mediterranean Diets Based on Organic and Conventional Foods

NCT03254537 | Unknown

• 1 other identifier: NUHEALTH-CS01-ORGANIC
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 2

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.

Conditions

Health Status

Outcome Measures

Primary Outcomes (10)

• IL-6 in Plasma measured using ELISA

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• IL-6 in WBC measured using ELISA

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• DNA damage in WBC measured using Western Blot

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• Total antioxidant activity in plasma measured using PENTRA

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• Phenols in plasma measured using GCMS

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• Carotenoids in plasma measured using GCMS

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• Pesticides in urine and plasma measured using ICPMS

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

• Isoprostanes in urine measured using ICPMS

  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

  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

  Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Study Arms (2)

Mediterranean Organic

EXPERIMENTAL

Dietary Supplement: Mediterranean Organic

Mediterranean conventional

EXPERIMENTAL

Dietary Supplement: Mediterranean conventional

Interventions

Mediterranean Organic DIETARY_SUPPLEMENT

Traditional Mediterranean diet comprised of organic ingredients

Mediterranean Organic

Mediterranean conventional DIETARY_SUPPLEMENT

Traditional Mediterranean diet comprised of conventional ingredients

Mediterranean conventional

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults No medications No known illness

You may not qualify if:

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

Sponsors & Collaborators

• Newcastle University: lead
• The Sheepdrove Trust: collaborator

Study Sites (2)

Levidopa Field Station

Sivas, Sivas Festos, GR 70200, Greece

Location

NU-Food Research Facility

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

Location

Related Publications (2)

• Rempelos L, Wang J, Baranski M, Watson A, Volakakis N, Hadall C, Hasanaliyeva G, Chatzidimitriou E, Magistrali A, Davis H, Vigar V, Srednicka-Tober D, Rushton S, Rosnes KS, Iversen PO, Seal CJ, Leifert C. Diet, but not food type, significantly affects micronutrient and toxic metal profiles in urine and/or plasma; a randomized, controlled intervention trial. Am J Clin Nutr. 2022 Nov;116(5):1278-1290. doi: 10.1093/ajcn/nqac233. Epub 2023 Feb 10.

  PMID: 36041176 DERIVED

• Rempelos L, Wang J, Baranski M, Watson A, Volakakis N, Hoppe HW, Kuhn-Velten WN, Hadall C, Hasanaliyeva G, Chatzidimitriou E, Magistrali A, Davis H, Vigar V, Srednicka-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.

  PMID: 34718382 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: August 18, 2017
• Study Start: May 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: December 31, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

GR (1); GB (1)