Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences
- Conditions
- Metabolic SyndromeOverweightObesity
- Interventions
- Other: Non-Personalized Nutrition PlanOther: Personalized Nutrition Plan
- Registration Number
- NCT04590989
- Lead Sponsor
- University of Copenhagen
- Brief Summary
The over-all aim of this 10-week randomized-controlled study, taking place only in Denmark, is to examine whether the PREVENTOMICS platform integrated in an e-commerce digital tool created to deliver personalized meals and dietary advices is able to produce more favorable health effects than meals based on general dietary recommendations in overweight subjects with elevated waist circumference.
- Detailed Description
PREVENTOMICs project (Empowering consumers to PREVENT diet-related diseases through OMICS sciences), coordinated by Eurecat (Spain), has developed a personalized nutrition platform with a Decision Support System (DSS) tool that integrates different disease-inducing metabolic signatures with genotype and other informative information such as the characteristics of individual's behavioural traits, to correlate health status and provide personalized nutritional plan.
To demonstrate the potential for personalization of the platform, PREVENTOMICS will be validated in three different scenarios through three different organizations carrying out intervention studies with both healthy volunteers and volunteers with abdominal obesity.
The current study in Denmark will be a 10-week double-blinded randomized (1:1 randomization), placebo-controlled trial carried out with overweight/obese subjects having elevated waist circumference living in Greater Copenhagen. After the confirmation of the inclusion criteria, 100 individuals will be randomly assigned to one of the two intervention groups. Both groups will receive meals from Simple Feast following the national guidelines of macronutrient composition. The control group (n=50) will receive meals based on general dietary recommendations whereas the meals of the second group (n=50) are personalized based on metabolic biomarkers (PP group). In addition, participants of both groups will receive electronic push notifications of behavioral change messages for the purpose of general behavioral change and improving adherence to the nutritional intervention, which will be sent during the 10-week trial by ONMI. However, subjects in the PP group will receive personally tailored and actionable behavior change prompts from the predefined ONMI's program while subjects in the control group will receive it in a non-personalized fashion with standard messages.
Our hypothesis is that delivery of personalized meal/plan through the PREVENTOMICS platform integrated with e-commerce digital tool, will promote a greater reduction in fat mass and weight, as well as producing favorable changes in blood metabolic and inflammatory biomarkers compared to the control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Men or women aged 18-65 years
- Body mass index (in kg/m2) of ≥27,0 and <40,0 (overweight and class I and II obesity)
- Elevated waist circumference (Men>94,0 cm; Women>80,0 cm)
- Possess a smart mobile phone
- Able to provide written informed consent
- Diagnosis of diabetes
- History or diagnosis of heart, liver or kidney disease
- Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
- Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the primary outcomes of the study
- Being lactating, pregnant or planning to become pregnant within the study period
- Participation within another clinical trial
- Other blood donation during the study
- Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening.
- Having allergies or food intolerances
- No or limited access to the Internet
- Participants not able to comply with the study protocol judged by Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Non-Personalized Nutrition Plan Dietary intervention: The second group of 50 subjects will receive meals from Simple Feast, after integrating their metabolic profile and other blood biomarkers by PREVENTOMICS, which are based on the national dietary guidelines. Behavioral intervention: Subjects will also receive nudges, after filling out ONMI's behavioral questionnaire at V2, but that will not be personalized (i.e. basic information that is available online from NHS and WHO). Personalized Plan (PP) Personalized Nutrition Plan Each subject in the PP group will be allocated to one of five clusters based on their metabolic and genetic health biomarkers from samples of urine, plasma, serum, and saliva. 58 biomarkers will be included to characterize the 5 metabolic clusters/processes in the PREVENTOMICS platform: 1) oxidative stress; 2) inflammation; 3) carbohydrate metabolism; 4) lipid metabolism; 5) microbiota-generated metabolites. Eurecat Nutrition Team has prepared a list of recommended food items to increase and food to exclude/limit from the diet for each cluster. The list will be adopted by Simple Feast in creating five different menus that will encompass the 12 meals/week of breakfasts and dinners for the five different metabolic clusters. Additionally, subjects will receive personalized actionable "Do's" push notifications by ONMI. The messages are personalized based on user reports from the behavioral questionnaire at V2 in addition to inputs from the nutritional recommendations of food to increase.
- Primary Outcome Measures
Name Time Method Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster). Baseline (V2) and week 10 (V3). Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.
- Secondary Outcome Measures
Name Time Method Change in body composition from baseline to week 10: visceral and subcutaneous fat, body lean mass, weight, body mass index, waist circumference Baseline (V2) and week 10 (V3). Body composition is evaluated by DXA scans at V2 and V3. Body weight will be measured after the participant has voided their bladder using a calibrated digital scale. weight will be recorded in kg to the nearest 0.1 kg. Body Mass Index (BMI) is calculated by the person's weight in kilograms divided by the square of their height in meters. Waist circumference will be measured with a stretch-resistant tape at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest. It will be measured twice to the nearest 0.5 cm and thereafter an average will be calculated.
Change in inflammatory biomarkers (fasting) - CRP, IL-6, MCP1, TNFα, IL-10, soluble ICAM1, soluble CD14 from baseline to week 10 Baseline (V2) and week 10 (V3). Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Change in lipid profile (fasting) from baseline to week 10: total, LDL and HDL cholesterol, triglycerides, atherogenic index of plasma (AIP) Baseline (V2) and week 10 (V3). Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Change in blood glucose, insulin, HOMA-IR (fasting) from baseline to week 10 Baseline (V2) and week 10 (V3). Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Change in adipokines (fasting) - Leptin, Adiponectin, Leptin/Adiponectin ratio from baseline to week 10 Baseline (V2) and week 10 (V3). Fasting blood samples will obtained after an overnight fast (from food and drinks except for water) for a minimum of 8 hours prior to the blood sampling.
Change in blood pressure from baseline to week 10 Baseline (V2) and week 10 (V3). Systolic and diastolic blood pressure and pulse will be measured using a validated automatic device on the arm after 5-10 min rest in a resting position. The measurement is taken three times with a 1 min rest in between (four times if the last two measurements deviate \>5 mmHg), and the reading is recorded to the nearest 1 mmHg. A mean value of the last two readings is used. The same arm will be used for all measurements at all visits.
Trial Locations
- Locations (1)
University of Copenhagen
🇩🇰Copenhagen, Frederiksberg, Denmark