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FLAVIOLA Health Study (FHS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799005
First Posted: February 26, 2013
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  Purpose
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.

Condition Intervention
Vascular Health Dietary Supplement: Flavanol (410 mg) Dietary Supplement: Control (no flavanols)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

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

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

Other Outcome Measures:
  • Flavanol metabolites [ Time Frame: 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. ]
  • Dietary pattern [ Time Frame: Time points: day 0 [baseline] and day 30 ]
  • Vascular stiffness [ Time Frame: 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. ]

Estimated Enrollment: 100
Study Start Date: February 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: flavanol rich intervention
Ingestion of 410mg flavanols twice a day for 30 days
Dietary Supplement: Flavanol (410 mg)
Other Name: 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 Name: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799005


Locations
Germany
Division of Cardiology, Pulmonology and Vascular Medicine
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, PD Dr. med. Christian Heiss, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01799005     History of Changes
Other Study ID Numbers: FHS
First Submitted: February 24, 2013
First Posted: February 26, 2013
Last Update Posted: February 3, 2015
Last Verified: February 2015

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
flavanols
diet
endothelial function
blood pressure
FLAVIOLA

Additional relevant MeSH terms:
Micronutrients
Growth Substances
Physiological Effects of Drugs