Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
试验速览
- 阶段
- 不适用
- 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
- 是
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
