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临床试验/NCT03254537
NCT03254537Unknown不适用

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

Newcastle University2 个研究点 分布在 2 个国家目标入组 27 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
27
试验地点
2
主要终点
IL-6 in Plasma measured using ELISA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults No medications No known illness

排除标准

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

研究组 & 干预措施

Mediterranean conventional

Experimental

干预措施: Mediterranean conventional (Dietary Supplement)

Mediterranean Organic

Experimental

干预措施: Mediterranean Organic (Dietary Supplement)

结局指标

主要结局

IL-6 in Plasma measured using ELISA

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

IL-6 in WBC measured using ELISA

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

DNA damage in WBC measured using Western Blot

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Total antioxidant activity in plasma measured using PENTRA

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Phenols in plasma measured using GCMS

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Carotenoids in plasma measured using GCMS

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Pesticides in urine and plasma measured using ICPMS

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

Isoprostanes in urine measured using ICPMS

时间窗: 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

时间窗: 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

时间窗: Change from baseline 2 weeks post supplementation and 4 weeks post supplementation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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