Healthy Aging Through Dietary Intervention

NCT ID: NCT05782309

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-02-05

Brief Summary

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

Detailed Description

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Conditions

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Aging, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Flavanol

500 mg of flavanols twice daily

Group Type EXPERIMENTAL

Flavanol

Intervention Type DRUG

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

Placebo

nutrient matched control capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Flavanol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Heinrich Heine University

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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 Oct 27. doi: 10.1039/d5fo02589c. Online ahead of print.

Reference Type DERIVED
PMID: 41143317 (View on PubMed)

Other Identifiers

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AgingEx

Identifier Type: -

Identifier Source: org_study_id

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