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Completed

NCT Number: NCT05782309

Healthy Aging Through Dietary Intervention

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

Completed

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Key information

Conditions

Aging, Healthy

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavanol

Drug

Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment

Placebo

Drug

Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment

Primary outcomes

  1. Exercise capacity

    Time frame: 30 days

    maximum power output during cardiopulmonary exercise testing

  2. peakVO2

    Time frame: 30 days

    maximum oxygen uptake during cardiopulmonary exercise testing

Secondary outcomes

  1. flow mediated vasodilation (FMD)

    Time frame: 30 days

    marker for vascular function

  2. Oxygen pulse

    Time frame: 30 days

    oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing

  3. aortic stiffness

    Time frame: 30 days

    cardiac magnetic resonance assessment of aortic diameter, distensibility and flow

  4. diastolic strain

    Time frame: 30 days

    cardiac magnetic resonance (CMR) based assessment of left ventricular strain

  5. Left ventricular function

    Time frame: 30 days

    systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle

  6. left atrial volume index (LAVi)

    Time frame: 30 days

    cardiac magnetic resonance based assessment of left atrial volume index

  7. brain natriuretic peptide (nt-proBNP)

    Time frame: 30 days

    blood chemistry, nt-proBNP measurement

  8. aortic pulse wave velocity (PWV)

    Time frame: 30 days

    cardiac magnetic resonance based assessment of pulse wave velocity in ascending and descending aorta

  9. diastolic strain rate (SR)

    Time frame: 30 days

    cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Mar 23, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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