Aging, HealthyNCT05782309
Healthy Aging Through Dietary Intervention
A study testing Flavanol in people with Aging, Healthy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy
- What is being tested?
- Flavanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2019to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50-79
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich Heine University
Düsseldorf, North Rhine-Westphalia, 40225
About this study
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
To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals
- Conditions
- Aging, Healthy
- Being tested
- Flavanol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavanolDrug
Assessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment
PlaceboDrug
Assessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment
| Study group | Role | What they receive |
|---|---|---|
| Flavanol | Experimental | 500 mg of flavanols twice daily Receives: Drug: Flavanol |
| Placebo | Placebo comparator | nutrient matched control capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
maximum power output during cardiopulmonary exercise testing
Measured: 30 days
peakVO2
maximum oxygen uptake during cardiopulmonary exercise testing
Measured: 30 days
Secondary outcomes (9)
flow mediated vasodilation (FMD)
marker for vascular function
Measured: 30 days
Oxygen pulse
oxygen uptake per heart beat (VO2/HR) as measured during cardiopulmonary exercise testing
Measured: 30 days
aortic stiffness
cardiac magnetic resonance assessment of aortic diameter, distensibility and flow
Measured: 30 days
diastolic strain
cardiac magnetic resonance (CMR) based assessment of left ventricular strain
Measured: 30 days
Left ventricular function
systolic ejection fraction calculated based on magnetic resonance volumetric assessment of left ventricle
Measured: 30 days
left atrial volume index (LAVi)
cardiac magnetic resonance based assessment of left atrial volume index
Measured: 30 days
brain natriuretic peptide (nt-proBNP)
blood chemistry, nt-proBNP measurement
Measured: 30 days
aortic pulse wave velocity (PWV)
cardiac magnetic resonance based assessment of pulse wave velocity in ascending and descending aorta
Measured: 30 days
diastolic strain rate (SR)
cardiac magnetic resonance (CMR) based assessment of left ventricular strain rate early and during atrial contraction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Apr 2019
- Primary completion30 Sep 2022
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782309
- Sponsor's protocol ID
- AgingEx
- Status last verified
- Sep 2023
- First submitted
- 9 Feb 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41143317
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05782309
- Acronym / sponsor ID
- AgingEx
- Conditions
- Aging, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flavanol | Experimental | Drug: Flavanol500 mg of flavanols twice daily |
| Placebo | Placebo comparator | Drug: Placebonutrient matched control capsule |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 50-79
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlavanolAssessement, supplementation for 30 days with either Placebo or Flavanols, Re-assessment | Drug | Flavanol |
| PlaceboAssessement, supplementation placebo for 30 days with either Placebo or Flavanols, Re-assessment | Drug | Placebo |
Primary outcome
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
9 secondary outcomes
flow mediated vasodilation (FMD)
Time frame: 30 days
Oxygen pulse
Time frame: 30 days
aortic stiffness
Time frame: 30 days
diastolic strain
Time frame: 30 days
Left ventricular function
Time frame: 30 days
left atrial volume index (LAVi)
Time frame: 30 days
brain natriuretic peptide (nt-proBNP)
Time frame: 30 days
aortic pulse wave velocity (PWV)
Time frame: 30 days
diastolic strain rate (SR)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 41143317Duse 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.
- Individual participant dataSharing planned: No
Related trials for Aging, Healthy
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
Healthy Volunteers, Aging, Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanol in people with Aging, Healthy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.