Effect of Mediterranean Diets Based on Organic and Conventional Foods
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.
研究概览
详细说明
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:
- 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.
- Quantify concentrations of pesticide residue, mineral, toxic metal and antioxidants in both organic and conventional food samples consumed during the intervention period
- 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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Mediterranean Organic
|
Traditional Mediterranean diet comprised of organic ingredients
|
|
实验性的:Mediterranean conventional
|
Traditional Mediterranean diet comprised of conventional ingredients
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
IL-6 in Plasma measured using ELISA
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
|
Change from baseline 2 weeks post supplementation and 4 weeks post supplementation
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NUHEALTH-CS01-ORGANIC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
健康状况的临床试验
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者完全的
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National... 和其他合作者尚未招聘
-
The Mediterranean Institute for the Advance of...Carlos III Health Institute; European Regional Development Fund; Andalusian Regional Ministry... 和其他合作者尚未招聘
-
Hopital MontfortChildren's Hospital of Eastern Ontario Research Institute招聘中热应激障碍 | 初级卫生保健 | 环境暴露 | 风险降低行为 | 公共卫生 | 热暴露 | 气候变化 | 预防保健服务 (PREV HEALTH SERV) | 健康主题加拿大