Here is the design of a clinical trial:

Official Title: PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study

Included conditions:
- Overweight
- Obesity
- Metabolic Syndrome

Study Armgroups:
- {'label': 'Personalized Plan (PP)', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Other: Personalized Nutrition Plan']}
- {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': "Dietary intervention:\n\nThe 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.\n\nBehavioral intervention:\n\nSubjects 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).", 'interventionNames': ['Other: Non-Personalized Nutrition Plan']}

Interventions:
- {'type': 'OTHER', 'name': 'Personalized Nutrition Plan', 'description': "* Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations.\n* Personalized behavioral change program via electronic push notifications by ONMI", 'armGroupLabels': ['Personalized Plan (PP)']}
- {'type': 'OTHER', 'name': 'Non-Personalized Nutrition Plan', 'description': "* Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized.\n* Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization).", 'armGroupLabels': ['Control Group']}

Primary Outcomes:
- {'measure': '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).', 'description': '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.', 'timeFrame': 'Baseline (V2) and week 10 (V3).'}

Please estimate the sample size based on the assumption: 
80% power, two-tailed significance level of 0.05, and an anticipated 18% dropout rate.
Power and sample size calculation
          To detect a difference in body fat mass change of 1.25 kg between the two intervention groups with 80% power at a two-tailed level of significance of 0.05, assuming a SD of 2.0 kg, a sample size of 41 per group (ie, personalised vs control) is needed, that is, a total sample size of 82 completers. To allow for an anticipated 18% dropout rate, 50 subjects per group would need to be recruited (total n=100). The expected difference in fat mass between groups (1.25 kg) and the associated SD (2.0 kg) were based on values calculated from the raw data of the SHOPUS study.47 In that study, we reported on body weight and fat mass during a 6-month dietary intervention in subjects with BMI of 22.6â47.3 kg/m2. To conduct power calculations for this study, we extracted raw data from the SHOPUS study that were most representative of the current subjects and intervention duration. Accordingly, we selected those SHOPUS participants with BMI â¥27 kg/m2 and elevated waist circumference (males >94 cm; females>80 cm) which represented more than 67% of the total study population (n=145) and assessed their body weight and fat mass at 12 weeks; this was an interim time point of the SHOPUS study (not published in the original paper),47 which was the closest to the 10-week time frame of the current intervention.