Healthy Aging Through Dietary Intervention

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Completed

CT.gov ID

NCT05782309

Collaborator

(none)

Enrollment

Location

Arms

46.2

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aging, Healthy	Drug: Flavanol Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Feb 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flavanol 410 mg of flavanols twice daily	Drug: Flavanol Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment
Placebo Comparator: Placebo nutrient matched control capsule	Drug: Placebo Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment

Arm

Intervention/Treatment

Experimental: Flavanol

410 mg of flavanols twice daily

Drug: Flavanol

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

Placebo Comparator: Placebo

nutrient matched control capsule

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Exercise capacity [30 days]
maximum power output during cardiopulmonary exercise testing
peakVO2 [30 days]
maximum oxygen uptake during cardiopulmonary exercise testing

Secondary Outcome Measures

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age 50-70,

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heinrich Heine University	Düsseldorf	NRW	Germany	40225

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heinrich-Heine University, Duesseldorf

ClinicalTrials.gov Identifier:

NCT05782309

Other Study ID Numbers:

AgingEx

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 23, 2023