NCT04102891

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: SmartWithFood · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Metabolic Syndrome
• Gut Bacteria
• Personalized Nutrition

Interventions

Type	Name	Description
OTHER	Microbiota modulation diet	The Collect\&Go shopping carts of the 400 participants will be adapted by replacing food products by healthier alternative ones based on the Flemish food-based dietary guidelines and the microbiota modulation diet guidelines for the control and study arm respectively. Based on these guidelines, and the habitual dietary pattern and level of food literacy of the participant, personalized dietary advice will be provided. A dietitian helpline will be available for further nutritional issues as well.

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2019-09-25
• Last updated: 2020-10-22