Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT04641559
Eligibility Criteria:
Inclusion Criteria:
* Men and women.
* Signed informed consent.
* To have internet access.
Exclusion Criteria:
* Diabetes (or glucose ≥ 126 mg/dL or pharmacological treatment).
* Hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or pharmacological treatment).
* Dyslipidaemia (cLDL ≥4.9 mmol/L and/or triglycerides ≥4.5 mmol/L (≥400 mg/dL) and/or cHDL \<40 mg/dL (1.03 mmol/L) in men and \<50 mg/dL (1.29 mmol/L) in women) or with pharmacological treatment.
* Use of prescribed medicine to control acute or chronic inflammation.
* Anaemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
* BMI (in kg/m2) \<18.5 or \>35.
* Being pregnant or planning to become pregnant within the study period.
* Be in breastfeeding period.
* Current smokers.
* Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
* Present some chronic gastrointestinal disease.
* Present some chronic disease with clinical manifestation, like coronary heart diseases, cardiovascular disease, coeliac disease, Crohn's disease and chronic kidney disease (or serum creatinine ≥1.7 mg/dL for men and ≥1.5 mg/dL for women).
* Following a prescribed diet for any reason, including weight loss, in the last 3 months.
* Following a pharmacological treatment for weight loss or intake of food supplements or medications that could affect body weight.
* Having allergies or food intolerances.
* No or limited access to the Internet.
* Consumption of more than 14 drinks of alcoholic beverages per week.
* Mediterranean Diet Adherence Score (MEDAS) \> 8 of 14 points, which is a food pattern already highly concordant with the Mediterranean Diet.
* Being unable to follow the study guidelines.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04641559
Study Brief:
Protocol Section:
NCT04641559