Clinical trial NCT04102891: Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Official title: Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Gut Bacteria
Personalized Nutrition
Keywords: Metabolic syndrome
Gut microbiota
Personalized dietary advice
Food literacy
Lead sponsor: SmartWithFood
Sponsor class: INDUSTRY
Collaborators: name: Vlaams Instituut voor Biotechnologie
name: KU Leuven
First posted: 2019-09-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduced waist circumference
timeFrame: 5 months
measure: Reduced serum triglycerides
timeFrame: 5 months
measure: Reduced blood pressure
timeFrame: 5 months
measure: Elevated HDL-cholesterol
timeFrame: 5 months
measure: Reduced fasting plasma glucose
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: