FLAVIOLA Health Study (FHS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01799005
First received: February 24, 2013
Last updated: August 18, 2014
Last verified: August 2014

February 24, 2013
August 18, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
Endothelial function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01799005 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
  • Glucose [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
  • Plasma lipids [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
Same as current
  • Flavanol metabolites [ Time Frame: day 0 [baseline], and day 30 each 0 and 2h ] [ Designated as safety issue: No ]
  • Microparticles [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
  • Dietary pattern [ Time Frame: Time points: day 0 [baseline] and day 30 ] [ Designated as safety issue: No ]
  • Vascular stiffness [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
  • Microvascular function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
Same as current
 
FLAVIOLA Health Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Vascular Health
  • Dietary Supplement: Flavanol (410 mg)
    Other Name: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
  • Dietary Supplement: Control (no flavanols)
    Other Name: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
  • Active Comparator: flavanol rich intervention
    Ingestion of 410mg flavanols twice a day for 30 days
    Intervention: Dietary Supplement: Flavanol (410 mg)
  • Placebo Comparator: flavanol free intervention
    Ingestion of a macro and micro nutrients matched flavanol free drink
    Intervention: Dietary Supplement: Control (no flavanols)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
35 Years to 60 Years
Yes
Contact: Christian Heiss, MD 02118118800 Christian.Heiss@med.uni-duesseldorf.de
Contact: Roberto Sansone, MD 02118108174 Roberto.Sansone@med.uni-duesseldorf.de
Germany
 
NCT01799005
FHS
No
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
Not Provided
Principal Investigator: Christian Heiss, MD Division of Cardiology, Pulmonology and Vascular Medicine
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonology and Vascular Medicine
Heinrich-Heine University, Duesseldorf
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP