Aging, Healthy
Conditions
Brief summary
To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals
Interventions
DRUGFlavanol
Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment
DRUGPlacebo
Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 30 days | maximum power output during cardiopulmonary exercise testing |
| peakVO2 | 30 days | maximum oxygen uptake during cardiopulmonary exercise testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen pulse | 30 days | oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing |
| diastolic strain | 30 days | cardiac magnetic resonance (CMR) based assessment of left ventricular strain |
| Left ventricular function | 30 days | systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle |
| aortic stiffness | 30 days | cardiac magnetic resonance assessment of aortic diameter, distensibility and flow |
| brain natriuretic peptide (nt-proBNP) | 30 days | blood chemistry, nt-proBNP measurement |
| aortic pulse wave velocity (PWV) | 30 days | cardiac magnetic resonance based assessment of pulse wave velocity in ascending and descending aorta |
| diastolic strain rate (SR) | 30 days | cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction |
| left atrial volume index (LAVi) | 30 days | cardiac magnetic resonance based assessment of left atrial volume index |
| flow mediated vasodilation (FMD) | 30 days | marker for vascular function |
Countries
Germany
Outcome results
None listed