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Clinical Trials/NCT05782309
NCT05782309
Completed
Not Applicable

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

Heinrich-Heine University, Duesseldorf1 site in 1 country68 target enrollmentApril 1, 2019
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ConditionsAging, Healthy
InterventionsFlavanolPlacebo
DrugsFlavanolPlacebo

Overview

Phase
Not Applicable
Intervention
Flavanol
Conditions
Aging, Healthy
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
68
Locations
1
Primary Endpoint
Exercise capacity
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
February 5, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Flavanol

500 mg of flavanols twice daily

Intervention: Flavanol

Placebo

nutrient matched control capsule

Intervention: Placebo

Outcomes

Primary Outcomes

Exercise capacity

Time Frame: 30 days

maximum power output during cardiopulmonary exercise testing

peakVO2

Time Frame: 30 days

maximum oxygen uptake during cardiopulmonary exercise testing

Secondary Outcomes

  • flow mediated vasodilation (FMD)(30 days)
  • Oxygen pulse(30 days)
  • aortic stiffness(30 days)
  • diastolic strain(30 days)
  • brain natriuretic peptide (nt-proBNP)(30 days)
  • aortic pulse wave velocity (PWV)(30 days)
  • Left ventricular function(30 days)
  • left atrial volume index (LAVi)(30 days)
  • diastolic strain rate (SR)(30 days)

Study Sites (1)

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