ong-term effects of a food pattern on cardiovascular risk factors and age-related changes of muscular and cognitive functio

Phase 4

• Conditions: I25.1; I25.29; I51.6; R29.6; F06.9; I64; I50.9; Muscle strength and muscle mass; I10.9; Heart failure, unspecified

• Registration Number: DRKS00010049
• Lead Sponsor: Medizinische Klinik für Endokrinologie, Diabetes und Ernährungsmedizin, Charité Universitätsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-12
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

At least one of the following criteria:
•Heart failure (NT-Pro-BNP >300ng/l)
•NYHA =II
•Cardiovascular disease (Blood pressure, stroke, heart infarction)
•Cognitive Impairment (Moca-Score <26)
•reduced of muscle strength (SPPB-Score <10)

Exclusion Criteria

•Instabile coronary heart disease
•Blood pressure values > 180 mmHg systolic and/or 110 mmHg diastolic
•Gait disturbance diseases for example Parkinson, Stroke with paresis
•endoprothesis
•Diabetes mellitus Typ 1
•Probands with Typ 2 Diabetes under Insulintherapy
•Severe hepatic and/ or kidney disease (raise of aminotransferase levels up to 3 times above the normal value and/or eGFR < 50 ml/min/1,73 m²)
•Severe symptomatic malignancy
•Severe systemic infection
•Severe mental illness
•Severe imunne disease
•Severe food allergy
•Severe malabsorption disease
•Oral steroid therapy
• not treated endocrine disease
•Drugs and/or alcohol abuse
•Eating disorders
•potentially unreliable probands
• participation in other study
• no health insurance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Endpoint consisting of cardiovascular morbidity (heart failure or coronary heart disease or revascularization or heart infarction or stroke or deterioriation of the blood pressure) or age-related changes (muscle strength or muscle mass or impairment of cognitive function). Here it should be proved that this intervention will lead to a lesser deterioration of at least one of the Endpoints. <br>In detail, cardiovascular disease: anamnesis (heart failure or coronary heart disease or revascularization or heart infarction or stroke ), blood pressure, control of the cardiovascular capacity: echocardiography (LVEF) baseline, after 1y and after 3y, hospitalization for heart failure.<br>Muscle strength and mass (SPPB, hand grip strength and dual-energy X-ray absorptiometry) at baseline, after 1y and 3y<br>Cognitive Function: [CERAD (TMT-A), WMS (digit span), Stroop (Wolfram)]: at baseline, after 1y and 3y<br>