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The effect of a low-calorie Mediterranean diet, intermittent fasting, and natural senolytics on aging markers in participants with low and high vascular risk

Effect of intervention with a low-calorie Mediterranean diet, intermittent fasting, and natural senolytics on aging markers in subjects with low and high vascular risk

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12085208
Enrollment
4000
Registered
2026-01-22
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of aging in patients with low to very high cardiovascular risk Signs and Symptoms

Interventions

All participants will undergo a standardized medical and lifestyle assessment, including detailed information on alcohol consumption, smoking status, and dietary patterns. • Randomization Randomizat

Sponsors

Instituto de Salud Carlos III
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Participants will be eligible for inclusion if they meet the following criteria: 1. Age: 50 ± 5 years or 80 ± 5 years. 2. Absence of established CVD, as define below. 3. Ability and willingness to comply with the study procedures and provide written informed consent Participants will be categorized at baseline into “high or very high vascular risk (H-VHVR) or “low-moderate vascular risk” (L-MVR) groups in accordance to accordance with the European Society of Cardiology (ESC) prevention guidelines and the SCORE 2 framework. High and Very High Vascular Risk (H/VHVR) Group Participants will be classified as H-VHVR if they meet at least one of the following criteria: 1. Diabetes mellitus for > 10 years, with or without of target organ damage (TOD), or Diabetes with > 1 additional major cardiovascular risk factor. 2. Severe hypertension: Blood pressure > 180/110 mm Hg, or requirement for > 3 antihypertensive drugs to achieve blood pressure control. 3. Severe Dyslipidemia: Untreated LDL cholesterol > 190 mg/dL (> 4.9 mmol/L), or current treatment with high-intensity statins with > 1 additional lipid-lowering therapy. 4. Moderate-to-severe renal disease Estimated glomerular filtration rate (eGFR) 3) 5. Current cigarette smoking. 6. Family history of premature CVD. First-degree relative with CVD onset <55 years in men or <65 years in women. Low and Moderate Vascular Risk (L-MVR) Group Participants aged 50 ± 5 years or 80 ± 5 years who do not meet any of the above vascular risk criteria will be classified as having low-to-moderate vascular risk, corresponding to SCORE 2 estimates below the high-risk threshold for their age and geographic region.

Exclusion criteria

Exclusion criteria: Participants will be excluded from the study if they present with any chronic condition associated with a senescent phenotype or other condition that could interfere with the intervention or outcome assessment, including: 1. Established cardiovascular disease (CVD): History of ischemic heart disease, stroke, or peripheral arterial disease. 2. Chronic kidney disease: Estimated glomerular filtration rate (GFR) 2B. 4. Acute or chronic heart failure within the previous 12 months: Diagnosed according to Framingham criteria. 5. Idiopathic pulmonary fibrosis. 6. Hematologic or solid organ cancer diagnosed within the past five years. 7. History of osteoporotic fracture, including femoral, radial, or vertebral compression fractures. 8. Liver cirrhosis. 9. Cognitive impairment of any etiology, defined as a Global Deterioration Scale (GDS) > 4. 10. Human immunodeficiency virus (HIV) infection. 11. Frailty, defined as a FRAIL score > 3 points and/or a VIG-Frail index > 0.2. 12. Systemic autoimmune disease. 13. Current treatment with anticoagulant therapy, due to potential interactions with fisetin. 14. Food allergies or intolerances that preclude adherence to the Mediterranean diet.

Countries

Spain

Contacts

Public ContactRamon Estruch
RESTRUCH@clinic.cat+34619761420

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026