Status:
UNKNOWN
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Lead Sponsor:
SmartWithFood
Collaborating Sponsors:
Vlaams Instituut voor Biotechnologie
KU Leuven
Conditions:
Metabolic Syndrome
Gut Bacteria
Eligibility:
All Genders
18+ years
Phase:
NA
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 pe...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Willingness to participate to the study and to sign the informed consent (Dutch)
- Older than 18 years
- Diagnosed with pre-metabolic syndrome (diagnosed with central obesity \[waist circumference ≥80 cm for women and ≥94 cm for men\] and one of the following criteria: elevated blood pressure \[systolic ≥130 mm Hg, diastolic ≥85 mm Hg\], raised triglycerides \[\>150 mg/dL\], reduced HDL-cholesterol \[\<40 mg/dL in men, \<50 mg/dL in women\], or raised fasting plasma glucose \[≥100 mg/dL\]
- Residing in Belgium, no travels abroad planned longer than seven consecutive days during the five-months study period
- Willingness to follow dietary guidelines during the three-months intervention period
- Willingness to purchase bulk groceries primarily at Colruyt Group using the Collect\&Go platform during the five-months study period
- Access to a -20-18°C freezer
- Exclusion criteria
- Chronic constipation (less than one defecation once a week)
- Gastro-intestinal surgery within the past 3 months
- Inflammatory bowel disease (IBD) or diverticulitis
- Irritable bowel syndrome (IBS)
- Any food allergy or food intolerance
- Metabolic syndrome
- Diabetes Mellitus Type 1 or Type 2
- Coeliac disease
- Pregnant women or women planning a pregnancy during the study period
- Lactating women
- Subjects on a specific diet (e.g. vegetarian/vegan diet, gluten-free diet, lactose-free diet, high-protein diet)
- Subjects being treated for hypertension or high cholesterol
Exclusion
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04102891
Start Date
February 1 2021
End Date
July 1 2021
Last Update
October 22 2020
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