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Effect of Mediterranean Diets Based on Organic and Conventional Foods

2017年8月17日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (予想される)

27

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Tyne and Wear
      • Newcastle upon Tyne、Tyne and Wear、イギリス、NE1 7RU
        • NU-Food Research Facility
    • Sivas Festos
      • Sivas、Sivas Festos、ギリシャ、GR 70200
        • Levidopa Field Station

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~40年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Mediterranean Organic
Traditional Mediterranean diet comprised of organic ingredients
実験的:Mediterranean conventional
Traditional Mediterranean diet comprised of conventional ingredients

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
IL-6 in Plasma measured using ELISA
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年5月1日

一次修了 (実際)

2017年8月1日

研究の完了 (予想される)

2017年12月31日

試験登録日

最初に提出

2017年6月21日

QC基準を満たした最初の提出物

2017年8月17日

最初の投稿 (実際)

2017年8月18日

学習記録の更新

投稿された最後の更新 (実際)

2017年8月18日

QC基準を満たした最後の更新が送信されました

2017年8月17日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • NUHEALTH-CS01-ORGANIC

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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健康状態の臨床試験

Mediterranean Organicの臨床試験

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