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Effect of Mediterranean Diets Based on Organic and Conventional Foods

17. August 2017 aktualisiert von: Newcastle University

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

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

27

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Sivas Festos
      • Sivas, Sivas Festos, Griechenland, GR 70200
        • Levidopa Field Station
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, Vereinigtes Königreich, NE1 7RU
        • NU-Food Research Facility

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Mediterranean Organic
Traditional Mediterranean diet comprised of organic ingredients
Experimental: Mediterranean conventional
Traditional Mediterranean diet comprised of conventional ingredients

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
IL-6 in Plasma measured using ELISA
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
IL-6 in WBC measured using ELISA
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
DNA damage in WBC measured using Western Blot
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Total antioxidant activity in plasma measured using PENTRA
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Phenols in plasma measured using GCMS
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Carotenoids in plasma measured using GCMS
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Pesticides in urine and plasma measured using ICPMS
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Isoprostanes in urine measured using ICPMS
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
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
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
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
Zeitfenster: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2017

Primärer Abschluss (Tatsächlich)

1. August 2017

Studienabschluss (Voraussichtlich)

31. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

21. Juni 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. August 2017

Zuerst gepostet (Tatsächlich)

18. August 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. August 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. August 2017

Zuletzt verifiziert

1. August 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • NUHEALTH-CS01-ORGANIC

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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