Healthy Aging Through Dietary Intervention

Study Overview
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Brief Summary
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To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals

Official Title
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Healthy Aging Through Dietary Intervention: Multiparametric Quantification of Function and Pathophysiology of the Aging Heart and Prevention of Age-associated Decline in Exercise Capacity Through Dietary Flavanols

Conditions
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Aging, Healthy

Intervention / Treatment
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* Drug: Flavanol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 50-79 Exclusion Criteria: non-cardiac limitations of exercise capacity such as orthopedic or neurological disorders, BMI >35 kg/m2, active smoking, uncontrolled blood pressure, diabetes, COPD, atrial fibrillation, cardiomyopathy, coronary heart disease, valvular heart disease, cardiac pacemaker, acute respiratory tract infections, missing ability or missing cooperation to participate in the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flavanol<br>500 mg of flavanols twice daily | Drug: Flavanol<br>* Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment<br>|
| Placebo Comparator: Placebo<br>nutrient matched control capsule | Drug: Placebo<br>* Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | maximum power output during cardiopulmonary exercise testing | 30 days | 
| peakVO2 | maximum oxygen uptake during cardiopulmonary exercise testing | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow mediated vasodilation (FMD) | marker for vascular function | 30 days | 
| Oxygen pulse | oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing | 30 days | 
| aortic stiffness | cardiac magnetic resonance assessment of aortic diameter, distensibility and flow | 30 days | 
| diastolic strain | cardiac magnetic resonance (CMR) based assessment of left ventricular strain | 30 days | 
| Left ventricular function | systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle | 30 days | 
| left atrial volume index (LAVi) | cardiac magnetic resonance based assessment of left atrial volume index | 30 days | 
| brain natriuretic peptide (nt-proBNP) | blood chemistry, nt-proBNP measurement | 30 days | 
| aortic pulse wave velocity (PWV) | cardiac magnetic resonance based assessment of pulse wave velocity in ascending and descending aorta | 30 days | 
| diastolic strain rate (SR) | cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction | 30 days |