Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102891
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Vlaams Instituut voor Biotechnologie
KU Leuven
Information provided by (Responsible Party):
SmartWithFood

Tracking Information
First Submitted Date  ICMJE September 18, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
Official Title  ICMJE Health Improvement Through Food and Lifestyle Intervention Based On Personalized Retail Advice
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Metabolic Syndrome
  • Gut Bacteria
  • Personalized Nutrition
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Study arm
    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.
    Intervention: Other: Microbiota modulation diet
  • No Intervention: Control arm
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102891
Other Study ID Numbers  ICMJE S63023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SmartWithFood
Study Sponsor  ICMJE SmartWithFood
Collaborators  ICMJE
  • Vlaams Instituut voor Biotechnologie
  • KU Leuven
Investigators  ICMJE Not Provided
PRS Account SmartWithFood
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP