Personalised Nutrition: An Integrative Analysis of Opportunities and Challenges
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,607
- 试验地点
- 9
- 主要终点
- Changes from baseline in Dietary Intake at 3 and 6 months
研究概览
简要总结
The concept of personalised nutrition emerged following the sequencing of the human genome in 2000. It was hoped that with the identification of gene nutrient interactions, an individual's response and susceptibility to particular diets would be better understood and therefore appropriate dietary modifications could be made to optimise health and lower disease risk. Then Food4Me aims to study the development of personalized nutrition at three levels and determine whether providing more personalised dietary advice leads to better compliance and health outcomes compared to standard population advice.
The hypotheses to be tested in the Food4Me study are as follows:
- Personalisation of dietary advice assists and/or motivates consumers to eat a healthier diet and follow a healthier lifestyle (in comparison with "impersonal" [conventional] dietary advice).
- Personalisation based on individualised biochemical (phenotypic) and/or genetic information is more effective in assisting and/or motivating study participants to make, and to sustain, appropriate healthy changes to their usual (habitual) diet and lifestyle.
详细描述
To achieve the Food4me aims, investigators will undertake a large multi-centre proof-of-principle study carried out across 7 EU countries on options for the delivery of personalised nutrition.
Recruitment Centres
Recruitment to the Food4Me intervention study will be carried out using identical protocols in 7 centres across the EU involving a total of 1,288 study participants i.e. 184 participants per country. The Proof-of-Proof of Principle study centres involve in the recruitment are:
- University College Dublin, Ireland.
- University of Maastricht, Netherlands.
- Universidad de Navarra, Spain.
- Harokopio University, Greece.
- The University of Reading, Uk
- National Food and Nutrition Institute, Poland.
- Technische Universitaet Muenchen, German.
Study design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged >18 years old
排除标准
- •Subject under 18 years old.
- •Pregnant or lactating.
- •No or limited access to internet.
- •Following a prescribed diet for any reason, including weight loss in the last 3 months.
- •Subjects under medication for Insulin dependent diabetes, celiac disease, Crohn's or any metabolic disease or condition that alters nutritional requirements, such as diabetes.
结局指标
主要结局
Changes from baseline in Dietary Intake at 3 and 6 months
时间窗: Baseline, month 3 and 6.
Habitual (usual) dietary intake will be measured using an on-line Food Frequency Questionnaire (FFQ). Intakes of nutrients will be computed using a food composition data base which has been augmented with country-specific food composition data. Changes in dietary pattern will be compared between baseline and month 3 and 6 in all participants.
次要结局
- Change from baseline in phenotypic and Metabolic biomarkers at 3 and 6 month(baseline, month 3 and 6)