ClinicalTrials.gov
ClinicalTrials.gov Menu

FLAVIOLA Health Study (FHS)

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.
ClinicalTrials.gov Identifier: NCT01799005
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Vascular Health Dietary Supplement: Flavanol (410 mg) Dietary Supplement: Control (no flavanols) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Other Outcome Measures:
  1. Flavanol metabolites [ Time Frame: day 0 [baseline], and day 30 each 0 and 2h ]
  2. Microparticles [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ]
  3. Dietary pattern [ Time Frame: Time points: day 0 [baseline] and day 30 ]
  4. Vascular stiffness [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ]
  5. Microvascular function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: February 26, 2013    Key Record Dates
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