Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04102891
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2019-09-18
Brief Title:
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Sponsor:
SmartWithFood
Organization:
SmartWithFood
Study Overview
Official Title:
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORA
Brief 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 CollectGo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None