Here is the design of a clinical trial:

Official Title: Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.

Included conditions:
- Acute Coronary Syndrome

Study Armgroups:
- {'label': 'Control', 'type': 'EXPERIMENTAL', 'description': 'In patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation', 'interventionNames': ['Other: Microbiota analysis', 'Other: Immunological analysis', 'Other: Proteome analysis', 'Other: Metabolome analysis', 'Other: Clinical evaluation', 'Other: Diet evaluation']}
- {'label': 'High-intensity MedDiet', 'type': 'EXPERIMENTAL', 'description': "Patients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation", 'interventionNames': ['Other: Microbiota analysis', 'Other: Immunological analysis', 'Other: Proteome analysis', 'Other: Metabolome analysis', 'Other: Clinical evaluation', 'Other: Diet evaluation', 'Other: MedDiet']}

Interventions:
- {'type': 'OTHER', 'name': 'Microbiota analysis', 'description': 'From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'Immunological analysis', 'description': 'A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'Proteome analysis', 'description': 'A study of host and microbiota proteome will be carried out from samples using mass spectrometry', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'Metabolome analysis', 'description': 'A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'Clinical evaluation', 'description': 'Clinical evaluation including hemostasis and biochemical studies', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'Diet evaluation', 'description': 'Biochemical analysis and questionaries for diet adherence and exercise registration', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}
- {'type': 'OTHER', 'name': 'MedDiet', 'description': 'The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (\\>40 g/d) for cooking and dressing dishes; b) consumption of \\>2 daily servings of vegetables; c) \\>2-3 daily serving of fresh fruits; d) \\>3 weekly servings of legumes; e) \\>3 weekly servings of fish or seafood; f) \\>1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses', 'armGroupLabels': ['High-intensity MedDiet']}

Primary Outcomes:
- {'measure': 'Fibrous cap thickness change', 'description': 'Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
Two-sample bilateral alpha error of 0.05, power of 0.80, and an attrition rate of 10%.
Sample size
        The sample size of the MEDIMACS clinical trial has been calculated on the assumption of an expected difference of 40% on the relative change in the fibrous cap thickness of the atherosclerotic plaque from baseline to 12âmonths between patients undergoing a high-intensity MedDiet intervention in comparison with the standard of care. This magnitude is a 10% lower than the difference previously reported using a similar design in a clinical trial comparing the effect on the fibrous cap of lipid-lowering therapy with 5âmg/day versus 20âmg/day atorvastatin, with an estimated standard deviation of 58% [37]. Based on a two-sample bilateral alpha error of 0.05 and a power of 0.80, the required number of patients is 35 per group. Assuming an attrition rate of 10%, 100 patients are needed to be randomized following a 1:1 allocation ratio. With this sample size, different scenarios could be contemplated under potential deviations from the expected effect size (Table 2).
Table 2Alternative scenarios for statistical power with n = 100 sample size, assuming 10% attrition ratesEffect sizePowerComment50%100%Effect addressed in EASY-FIT Study40%99.60%Baseline assumptions30%93.45%Effect 25% relatively lower than expected
        Regarding the suitability of this sample size to evaluate the secondary endpoints, micro- and macrovascular endothelial functions are proven to be highly sensitive to detect meaningful effects using small sample populations (50â100 patients) [38, 39]. Microbiota, immunological and metabolic changes in response to diet interventions have been widely reported using small sample populations (20â50 patients), particularly under pathological conditions [40, 41].