PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).
研究概览
简要总结
The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general dietary recommendations in overweight subjects with elevated waist circumference.
详细描述
PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan.
To demonstrate the potential for personalization of the platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity.
The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast following the national guidelines of macronutrient composition. The control group (n=50) will receive meals based on general dietary recommendations whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages.
Our hypothesis is that delivery of personalized meal/plan through the PREVENTOMICS platform integrated with e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be randomly allocated to either intervention group (personalized plan) or control group prior to commencement of the trial. The allocation will be computer generated, and stratified by metabolic clusters (oxidative stress; inflammation; carbohydrate metabolism; lipid metabolism; microbiota-generated metabolites) in a 1:1 randomization between control and intervention groups. The person responsible for generating the code will not take part in the inclusion and examination of study participants. Study staff at UCPH and participants will be blinded to the treatment group and analyses of results will be performed in a blinded fashion. Moreover, the statistical analyses of the main outcome variable will be done without breaking the code for the intervention treatment, before the primary analyses are finalized.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 18-65 years
- •Body mass index (in kg/m2) of ≥27,0 and <40,0 (overweight and class I and II obesity)
- •Elevated waist circumference (Men>94,0 cm; Women>80,0 cm)
- •Possess a smart mobile phone
- •Able to provide written informed consent
排除标准
- •Diagnosis of diabetes
- •History or diagnosis of heart, liver or kidney disease
- •Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
- •Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the primary outcomes of the study
- •Being lactating, pregnant or planning to become pregnant within the study period
- •Participation within another clinical trial
- •Other blood donation during the study
- •Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening.
- •Having allergies or food intolerances
- •No or limited access to the Internet
- •Participants not able to comply with the study protocol judged by Investigator
结局指标
主要结局
Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).
时间窗: Baseline (V2) and week 10 (V3).
Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.
次要结局
- Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference(Baseline (V2) and week 10 (V3).)
- Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10(Baseline (V2) and week 10 (V3).)
- Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP)(Baseline (V2) and week 10 (V3).)
- Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10(Baseline (V2) and week 10 (V3).)
- Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10(Baseline (V2) and week 10 (V3).)
- Change in blood pressure from baseline to week 10(Baseline (V2) and week 10 (V3).)
研究者
Mads Fiil Hjorth
Associate Professor, Head of Obesity Research Section
University of Copenhagen