FLAVIOLA Health Study (FHS)

February 1, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Division of Cardiology, Pulmonology and Vascular Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male, age 35-60 years, healthy
  • female, age 35-60 years, healthy

Exclusion Criteria:

  • diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: flavanol rich intervention
Ingestion of 410mg flavanols twice a day for 30 days
Dietary supplement: Flavanol (410 mg)
Other Names:
  • Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
Placebo Comparator: flavanol free intervention
Ingestion of a macro and micro nutrients matched flavanol free drink
Dietary supplement: Control (no flavanols)
Other Names:
  • Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.
Glucose
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.
Plasma lipids
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.

Other Outcome Measures

Outcome Measure
Time Frame
Flavanol metabolites
Time Frame: day 0 [baseline], and day 30 each 0 and 2h
day 0 [baseline], and day 30 each 0 and 2h
Microparticles
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.
Dietary pattern
Time Frame: Time points: day 0 [baseline] and day 30
Time points: day 0 [baseline] and day 30
Vascular stiffness
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.
Microvascular function
Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Time points: day 0 [baseline], and day 30 each 0 and 2h.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
  • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonology and Vascular Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 24, 2013

First Submitted That Met QC Criteria

February 24, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 1, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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