Personalized Nutrition Advice Based on Metabolic Profiling and Behaviour Assessment for Optimizing Dietary Habits and Metabolic Status. Single Blind, Parallel, Randomized, Controled Intervention Trial (EUT_PREVENTOMICS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Change in Adherence to Mediterranean diet.
研究概览
简要总结
The alteration maintained over time of some metabolic processes, such as oxidative stress, low-grade inflammation, carbohydrate and lipid metabolism, and of the intestinal microbiota activity, can induce some chronic diseases with high prevalence in society, such as obesity, cardiovascular disease or diabetes. These metabolic alterations can be modulated through nutrition and eating habits. Thus nutritional interventions are currently considered as a main tool for disease prevention.
The need to adapt nutritional interventions to the particular needs of each person in order to improve the health status of all individuals is becoming more and more evident, through precision nutrition. On the other hand, for nutritional interventions to be carried out over long periods of time and to achieve sustainable long-term changes in lifestyle, new forms of behavioral counseling are necessary to facilitate the follow-up of nutritional interventions.
PREVENTOMICS is a European project that arose to develop a personalized nutrition system, the PREVENTOMICS system. This system is based on the classification of the users of the system according to the state of their own metabolic processes, their genotype, their dietary habits and preferences, levels of physical activity, purchase preference and possible allergies, in order to provide a personalized nutrition adapted to the needs of each user.
The PREVENTOMICS system is presented through a digital environment via computer, with a list of products provided by the ALDI supermarket to prepare the shopping list, without having to buy the products from the ALDI supermarket.
详细描述
Nowadays, diet is recognized as one of the most important factors in the development of non-communicable diseases. Therefore, nutrition and dietary habits stand out as an invaluable tool for preventing diseases. Among these dietary habits, Mediterranean diet is now recognized as one of the best models of food patterns providing protection against chronic diseases and with beneficial effects on quality of life.
During the last years, expectation on precision nutrition beyond personalized diet has been increasing due to the possibility of adapting diet to the actual needs of the person, optimizing the function of the organism. Currently, diet precision in the context of general population is mainly addressed to heterogeneous groups of population, depending on variables such as age, gender or physical state among others. Beyond this approach, a more accurate personalization strategy is based on adapting some components of the diet to the genetic profile of the subject while considering a limited number of phenotypical traits.
Some authors have proposed that a wide array of chronic non-communicable diseases of high prevalence in our society have a multifactorial origin, being the result of a sustained dysregulation of some physiological processes, such as metabolic stress, oxidative stress, chronic systemic low-grade inflammation or psychological stress among others. Since most of these processes can be modulated by diet, optimizing them by means of nutritional interventions could represent an invaluable approach for preventing diseases. Nevertheless, a complete characterization of these physiological processes is needed in order to know their real state in individuals and be able to deliver an adequate intervention for their restoration when required. Currently, -omics technologies provide the necessary tools for accurate assessing the state of these physiological processes.
In this context, PREVENTOMICS project financed by the European Research and Innovation programme H2020 (Call H2020-SFS-2018-2020; DT-SFS-14-2018; Project title : Empowering consumers to PREVENT diet-related diseases through OMICS sciences) and with a consortium of different companies and public entities, including EURECAT, aims to assess the most relevant metabolic processes which dysregulation leads to the onset of disease and to integrate individual's metabolic signature with genetic, biological, nutritional and psychological aspects through Information and communication Technologies (ICTs) to deliver preventive personalized nutrition tools in order to correct early deviations.
The main concept behind the PREVENTOMICS project is to provide personalized recommendations based on a multi-level classification after clustering the different users according to their dietary habits and preferences, their levels of physical activity, shopping preferences, possible allergies and phenotypic (i.e. metabolomics and proteomics-based multivariate approach) and genotype characterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Men and women.
- •Signed informed consent.
- •To have internet access.
排除标准
- •Diabetes (or glucose ≥ 126 mg/dL or pharmacological treatment).
- •Hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or pharmacological treatment).
- •Dyslipidaemia (cLDL ≥4.9 mmol/L and/or triglycerides ≥4.5 mmol/L (≥400 mg/dL) and/or cHDL <40 mg/dL (1.03 mmol/L) in men and <50 mg/dL (1.29 mmol/L) in women) or with pharmacological treatment.
- •Use of prescribed medicine to control acute or chronic inflammation.
- •Anaemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
- •BMI (in kg/m2) <18.5 or >
- •Being pregnant or planning to become pregnant within the study period.
- •Be in breastfeeding period.
- •Current smokers.
- •Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Present some chronic gastrointestinal disease.
- •Present some chronic disease with clinical manifestation, like coronary heart diseases, cardiovascular disease, coeliac disease, Crohn's disease and chronic kidney disease (or serum creatinine ≥1.7 mg/dL for men and ≥1.5 mg/dL for women).
- •Following a prescribed diet for any reason, including weight loss, in the last 3 months.
- •Following a pharmacological treatment for weight loss or intake of food supplements or medications that could affect body weight.
- •Having allergies or food intolerances.
- •No or limited access to the Internet.
- •Consumption of more than 14 drinks of alcoholic beverages per week.
- •Mediterranean Diet Adherence Score (MEDAS) > 8 of 14 points, which is a food pattern already highly concordant with the Mediterranean Diet.
- •Being unable to follow the study guidelines.
结局指标
主要结局
Change in Adherence to Mediterranean diet.
时间窗: At weeks 2 and 25.
Adherence to Mediterranean diet measured through the MEditerranean Diet Adherence Screener (MEDAS). The questionnaire consists of 14 questions about eating habits, the frequency of consumption of typical foods of the Mediterranean diet or the consumption of foods not recommended in this diet. Each question is screened with 0 (non-compliant) or 1 (compliant) and the total score range from 0 to 14, so a score of 14 points mean maximum adherence.
次要结局
- Change in body weight.(At weeks 2 and 25)
- Height.(At weeks 2)
- Change in BMI(At weeks 2 and 25)
- Change in waist circumference.(At weeks 2 and 25)
- Change in blood pressure (in mmHg).(At weeks 2 and 25)
- Change in serum urea levels.(At weeks 2 and 25)
- Change in serum uric acid levels.(At weeks 2 and 25)
- Change in urinalysis.(At weeks 2 and 25)
- Change in blood cell count.(At weeks 2 and 25)
- Change in serum creatinine levels.(At weeks 2 and 25)
- Change in serum bilirubin levels.(At weeks 2 and 25)
- Change in serum ions levels.(At weeks 2 and 25)
- Change in serum proteins levels.(At weeks 2 and 25)
- Change in serum aspartate aminotransferase levels.(At weeks 2 and 25)
- Change in serum alanine aminotransferase levels.(At weeks 2 and 25)
- Change in plasma IL-6 levels.(At weeks 2 and 25)
- Change in serum ARA and EPA levels.(At weeks 2 and 25)
- Change in plasma TNFα levels.(At weeks 2 and 25)
- Change in plasma MCP-1 levels.(At weeks 2 and 25)
- Change in plasma IL-8 levels.(At weeks 2 and 25)
- Change in plasma soluble ICAM1 levels.(At weeks 2 and 25)
- Change in plasma lysophosphatidylcholine levels.(At weeks 2 and 25)
- Change in plasma soluble CD14 levels.(At weeks 2 and 25)
- Change in urine N-acetylglycoproteins levels.(At weeks 2 and 25)
- Change in serum total PUFAs levels.(At weeks 2 and 25)
- Change in urine acetate levels.(At weeks 2 and 25)
- Change in plasma leptin levels(At weeks 2 and 25)
- Change in urine fucose levels.(At weeks 2 and 25)
- Change in serum DHA levels.(At weeks 2 and 25)
- Change in serum linoleic acid levels.(At weeks 2 and 25)
- Change in serum acetate levels.(At weeks 2 and 25)
- Change in urine TMAO levels.(At weeks 2 and 25)
- Change in serum lactate levels.(At weeks 2 and 25)
- Change in urine TMA levels.(At weeks 2 and 25)
- Change in plasma glucose levels(At weeks 2 and 25)
- Change in urine lactate levels.(At weeks 2 and 25)
- Change in urine DMA levels.(At weeks 2 and 25)
- Change in plasma LPS levels.(At weeks 2 and 25)
- Change in plasma insulin levels(At weeks 2 and 25)
- Change in plasma adiponectin levels(At weeks 2 and 25)
- Genotyping analysis(At week 2)
- Change in urine α-hydroxybutyrate levels(At weeks 2 and 25)
- Change in urine α-ketoglutarate levels(At weeks 2 and 25)
- Change in nutrition habits(At weeks 2 and 25)
- Change in urine succinate levels(At weeks 2 and 25)
- Change in urine malate levels(At weeks 2 and 25)
- Change in plasma acylcarnitine profile levels(At weeks 2 and 25)
- Change in the atherogenic index of plasma(At weeks 2 and 25)
- Change in urine fumarate levels(At weeks 2 and 25)
- Change in physical activity(At weeks 2 and 25)
- Change in person's global perception in life related to being overweight and trying to lose weight.(At weeks 2 and 25)
- Change in dietary intake(At weeks 2 and 25)
- Change in satisfaction with weight-management diets.(At weeks 2 and 25)
- Change in person's perceptions in life related to mobility, self-care, usual activities, paint/discomfort and anxiety/depression.(At weeks 2 and 25)
- Change in hip circumference(At weeks 2 and 25)
- Change in HOMA-IR levels(At weeks 2 and 25)
- Change in plasma non-HDL-cholesterol levels(At weeks 2 and 25)
- Change in serum total MUFAs levels(At weeks 2 and 25)
- Change in serum oleic acid levels(At weeks 2 and 25)
- Change in urine 8-iso-prostaglandin F2α levels(At weeks 2 and 25)
- Change in body composition(At weeks 2 and 25)
- Change in leptin to adiponectin ratio(At weeks 2 and 25)
- Change in plasma total cholesterol levels(At weeks 2 and 25)
- Change in plasma HDL-cholesterol levels(At weeks 2 and 25)
- Change in plasma LDL-cholesterol levels(At weeks 2 and 25)
- Change in plasma triglycerides levels(At weeks 2 and 25)
- Change in plasma 3-Nitrotyrosine levels(At weeks 2 and 25)
- Change in urine Pseudouridine levels(At weeks 2 and 25)
- Change in plasma total lysophosphatidylcholine levels(At weeks 2 and 25)
- Change in urine 8-hydroxy-2'-deoxyguanosine levels(At weeks 2 and 25)
- Metabolomics for consumption biomarkers(At weeks 2 and 25)