Reducing saturated fat in a Mediterranean diet to lower cardiovascular risk
Cardiovascular Risk Prevention With a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED): Randomized Controlled Dietary Intervention Study With Metabolomic and Gut Microbiome Analyses
This study is testing if a Mediterranean diet with less saturated fat can help adults with high cholesterol lower their risk of heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT05778656 on ClinicalTrials.gov |
What this trial studies
The CADIMED study is a randomized, controlled intervention that aims to evaluate the effects of a Mediterranean dietary pattern with reduced saturated fat intake, specifically by eliminating red and processed meat. It will involve 156 adult participants with dyslipidemia, comparing those who follow the dietary intervention to a control group adhering to standard health advice for cardiovascular disease prevention. The study will assess changes in cardiovascular risk biomarkers, blood metabolomics, and the microbiome over an 8-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with elevated LDL cholesterol levels who are motivated to improve their diet.
Not a fit: Patients with familial hypercholesterolemia or those currently on lipid-lowering medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower LDL cholesterol levels and reduce cardiovascular disease risk in patients.
How similar studies have performed: Previous studies have shown that reducing saturated fat intake can significantly lower LDL cholesterol and cardiovascular events, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Granada
- University of Granada — Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Carmen Piernas, PhD — Universidad de Granada
- Study coordinator: Carmen Piernas, PhD
- Email: carmenpiernas@ugr.es
- Phone: 615210894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.