跳至主要内容
临床试验/NCT04102891
NCT04102891Unknown不适用

Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice

SmartWithFood0 个研究点目标入组 400 人开始时间: 2021年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
SmartWithFood
入组人数
400
主要终点
Reduced waist circumference

研究概览

简要总结

FLORA is a longitudinal intervention study with a randomized, parallel group design. Primary objective is to improve metabolic health through gut microbiota modulation by means of a retailer-driven personalized dietary intervention in a real-life setting. Four hundred Flemish pre-metabolic adults will be randomly divided into a control and treatment arm, each comprising 200 participants. The study period is divided into three phases: a four weeks characterization, a twelve weeks intervention, and a four weeks post-intervention phase. During the intervention phase, control participants' online Collect&Go shopping carts are adjusted in accordance with Flemish food-based dietary guidelines. Based on the same guidelines, participants are provided with personalized dietary advice considering their usual dietary pattern and level of food literacy. In the treatment arm, a similar intervention will be applied using guidelines based on a microbiota modulation diet (MMD). During intervention, all participants can contact a dietician helpline for additional advice on study-related dietary issues. Over the five months, saliva and fecal samples will be collected on a regular basis, with an intensive sampling period of seven consecutive days at the end of each study phase. A GP consult consisting of a short medical exam, blood withdrawal and medical questionnaire takes place each month. Further, online questionnaires on lifestyle, health and well-being will be sent by e-mail and each five days, participants complete a food diary through their smartphone. Fecal, saliva, blood samples and meta-data will be analysed to detect changes in metabolic health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Reduced waist circumference

时间窗: 5 months

Participants' waist circumference (cm) decreases during the study period

Reduced serum triglycerides

时间窗: 5 months

Participants' serum triglyceride level (mg/dL) decreases during the study period (blood sample analysis)

Reduced blood pressure

时间窗: 5 months

Participants' blood pressure (mm Hg) decreases during the study period

Reduced fasting plasma glucose

时间窗: 5 months

Participants' fasting plasma glucose levels decrease during the study period (blood sample analysis)

Elevated HDL-cholesterol

时间窗: 5 months

Participants' HDL-cholesterol levels (mg/dL) increase during the study period (blood sample analysis)

次要结局

未报告次要终点

研究者

发起方
SmartWithFood
申办方类型
Industry
责任方
Sponsor

相似试验