Cardiovascular Risk Prevention With a Mediterranean Dietary Pattern Reduced in Saturated Fat

Launched by UNIVERSIDAD DE GRANADA · Mar 9, 2023

Keywords

ClinConnect Summary

The CADIMED study is researching whether changing your diet by cutting out red and processed meats can help lower cholesterol levels and reduce the risk of heart disease. The trial involves 156 adults aged 18 to 75 who have high levels of LDL cholesterol (often referred to as "bad" cholesterol). Participants will be divided into two groups: one will follow a special diet that eliminates red and processed meats, while the other will receive general health advice for heart disease prevention. The study will look at how these dietary changes affect cholesterol levels and other health markers over an 8-week period.

To be eligible for this trial, you need to be between 18 and 75 years old and have high LDL cholesterol levels but not require medication for cholesterol management. You should also be comfortable using the internet to participate. However, certain individuals, such as those on cholesterol-lowering medications or with serious health conditions, won't be able to join. If you decide to participate, you'll be helping researchers understand how dietary changes can improve heart health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent form.
• • Age ≥18 years to ≤75 years.
• • With indication to start lifestyle intervention based on recent values (e.g., last 3-6 months) of LDL-C ≥ 116 mg/dl and \< 190 mg/dl; or as long as pharmacological treatment has not been advised and started (ESC/EAS Guide, Rev Esp Cardiol. 2020).
• • Access to a device (e.g., smartphone, tablet, computer) with internet and digital skills to use the website.
• • Motivation and willingness to be assigned to any group to improve their diet and commitment to perform the designated protocol.
• Exclusion Criteria:
• • Patients with familial hypercholesterolemia and/or on treatment with lipid-lowering drugs (including statins, ezetimibe, PCSK9 inhibitors, fibrates, bile acid sequestrants, omega-3 fatty acids, nicotinic acid/Vit B3), dietary supplements or functional foods for the treatment of dyslipidemia (plant sterols, monacolin, red yeast rice, fiber supplements 3-10 g (Plantago), policosanol, berberine, and soy protein/lecithin) in the last 3 months.
• • High cardiovascular risk that requires pharmacological treatment, for example, patients with recent and/or established CVD, type 1 and 2 diabetes.
• • Uncompensated thyroid function disorders; relevant comorbidities (including liver failure and cholestasis, chronic kidney disease, Cushing's syndrome, nephrotic syndrome, class III obesity - BMI ≥ 40 kg/m²); cancer; psychiatric disorders and/or that in the opinion of the investigator hinder the fulfillment or follow-up of the study.
• • Excessive alcohol consumption: \> 40 g/d (4 UBEs/day) in men and \> 20-25 g/d (2-2.5 UBEs/day) in women (Ministry of Health, July 2020).
• • Pregnancy, lactation, perimenopause (amenorrhea \< 1 year) and women who change, start, or finish their treatment with hormonal contraceptives during the study.
• • Enrollment in other research studies or following restricted eating patterns (e.g., vegetarians and vegans) that could interfere with study requirements.
• • Failure to grant informed consent or not complete the initial assessment.