Metabolic SyndromeFLORANCT04102891
Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
A study testing Microbiota modulation diet in people with Metabolic Syndrome and Gut Bacteria, run by SmartWithFood.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Gut Bacteria, Personalized Nutrition
- What is being tested?
- Microbiota modulation diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
- Being tested
- Microbiota modulation diet
- Keywords
- Metabolic syndrome, Gut microbiota, Personalized dietary advice, Food literacy
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota modulation dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | During the three months intervention period, participants within this arm will do their groceries through the online Collect\&Go platform of Colruyt Group. Dietitians will adjust their shopping carts by changing food products by healthier alternative ones taking into account the Flemish food-based dietary guidelines. Based on participants' dietary pattern and level of food literacy, personalized dietary advice will be provided and a dietitian helpline will be available for further nutrition-related questions. Receives: Other: Microbiota modulation diet |
| Control arm | No intervention | During the three months intervention period, participants within this arm will do their groceries through the online Collect\&Go platform of Colruyt Group. Dietitians will adjust their shopping carts by changing food products by healthier alternative ones taking into account the guidelines from the newly developed microbiota modulation diet (MMD). Based on participants' dietary pattern and level of food literacy, personalized dietary advice will be provided and a dietitian helpline will be available for further nutrition-related questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced waist circumference
Participants' waist circumference (cm) decreases during the study period
Measured: 5 months
Reduced serum triglycerides
Participants' serum triglyceride level (mg/dL) decreases during the study period (blood sample analysis)
Measured: 5 months
Reduced blood pressure
Participants' blood pressure (mm Hg) decreases during the study period
Measured: 5 months
Elevated HDL-cholesterol
Participants' HDL-cholesterol levels (mg/dL) increase during the study period (blood sample analysis)
Measured: 5 months
Reduced fasting plasma glucose
Participants' fasting plasma glucose levels decrease during the study period (blood sample analysis)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SmartWithFood
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Flemish institute of biotechnology (VIB), KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102891
- Sponsor's protocol ID
- S63023
- Acronym
- FLORA
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
- ClinicalTrials.gov ID
- NCT04102891
- Acronym / sponsor ID
- FLORA / S63023
- Conditions
- Metabolic Syndrome, Gut Bacteria, Personalized Nutrition
- Keywords
- Metabolic syndrome, Gut microbiota, Personalized dietary advice, Food literacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SmartWithFoodIndustry (pharma, biotech, devices)
- Collaborators
- Flemish institute of biotechnology (VIB), KU Leuven
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Other: Microbiota modulation dietDuring the three months intervention period, participants within this arm will do their groceries through the online Collect\&Go platform of Colruyt Group. Dietitians will adjust their shopping carts by changing food products by healthier alternative ones taking into account the Flemish food-based dietary guidelines. Based on participants' dietary pattern and level of food literacy, personalized dietary advice will be provided and a dietitian helpline will be available for further nutrition-related questions. |
| Control arm | No intervention | –During the three months intervention period, participants within this arm will do their groceries through the online Collect\&Go platform of Colruyt Group. Dietitians will adjust their shopping carts by changing food products by healthier alternative ones taking into account the guidelines from the newly developed microbiota modulation diet (MMD). Based on participants' dietary pattern and level of food literacy, personalized dietary advice will be provided and a dietitian helpline will be available for further nutrition-related questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota modulation dietThe 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. | Other | Study arm |
Primary outcome
Reduced waist circumference
Time frame: 5 months
Participants' waist circumference (cm) decreases during the study period
Reduced serum triglycerides
Time frame: 5 months
Participants' serum triglyceride level (mg/dL) decreases during the study period (blood sample analysis)
Reduced blood pressure
Time frame: 5 months
Participants' blood pressure (mm Hg) decreases during the study period
Elevated HDL-cholesterol
Time frame: 5 months
Participants' HDL-cholesterol levels (mg/dL) increase during the study period (blood sample analysis)
Reduced fasting plasma glucose
Time frame: 5 months
Participants' fasting plasma glucose levels decrease during the study period (blood sample analysis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiota modulation diet in people with Metabolic Syndrome and Gut Bacteria, run by SmartWithFood.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced waist circumference (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.