Healthy Aging Through Dietary Intervention

Not Applicable

Completed

• Conditions: Aging, Healthy
• Interventions: Drug: Flavanol; Drug: Placebo

• Registration Number: NCT05782309
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-02-05
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flavanol	Flavanol	500 mg of flavanols twice daily
Placebo	Placebo	nutrient matched control capsule

Primary Outcome Measures

Name	Time	Method
peakVO2	30 days	maximum oxygen uptake during cardiopulmonary exercise testing
Exercise capacity	30 days	maximum power output during cardiopulmonary exercise testing

Secondary Outcome Measures

Name	Time	Method
flow mediated vasodilation (FMD)	30 days	marker for vascular function
Oxygen pulse	30 days	oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing
aortic stiffness	30 days	cardiac magnetic resonance assessment of aortic diameter, distensibility and flow
diastolic strain	30 days	cardiac magnetic resonance (CMR) based assessment of left ventricular strain
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
Left ventricular function	30 days	systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle
left atrial volume index (LAVi)	30 days	cardiac magnetic resonance based assessment of left atrial volume index
diastolic strain rate (SR)	30 days	cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction

Trial Locations

Locations (1)

Heinrich Heine University; 🇩🇪 Düsseldorf, NRW, Germany