NCT05782309

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

February 9, 2023

Last Update Submit

September 21, 2023

Conditions

Aging, Healthy

Outcome Measures

Primary Outcomes (2)

  • Exercise capacity

    maximum power output during cardiopulmonary exercise testing

    30 days

  • peakVO2

    maximum oxygen uptake during cardiopulmonary exercise testing

    30 days

Secondary Outcomes (9)

  • flow mediated vasodilation (FMD)

    30 days

  • Oxygen pulse

    30 days

  • aortic stiffness

    30 days

  • diastolic strain

    30 days

  • Left ventricular function

    30 days

  • +4 more secondary outcomes

Study Arms (2)

Flavanol

EXPERIMENTAL

500 mg of flavanols twice daily

Drug: Flavanol

Placebo

PLACEBO COMPARATOR

nutrient matched control capsule

Drug: Placebo

Interventions

FlavanolDRUG

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

Flavanol
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 50-79

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • Duse DA, Grone M, Ophoff N, Kramser N, Schweers H, Ottaviani J, Schroeter H, Quast C, Bonner F, Heiss C, Sansone R, Jung C, Kelm M, Erkens R. Cocoa flavanols alleviate early diastolic dysfunction by decreasing left atrial volume in a randomized double blinded trial in healthy older individuals. Food Funct. 2025 Nov 10;16(22):8836-8845. doi: 10.1039/d5fo02589c.

    PMID: 41143317DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 23, 2023

Study Start

April 1, 2019

Primary Completion

September 30, 2022

Study Completion

February 5, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)