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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799005

Contacts
Contact: Christian Heiss, MD 02118118800 Christian.Heiss@med.uni-duesseldorf.de
Contact: Roberto Sansone, MD 02118108174 Roberto.Sansone@med.uni-duesseldorf.de

Locations
Germany
Division of Cardiology, Pulmonology and Vascular Medicine Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Roberto Sansone, MD    02118108174    Roberto.Sansone@med.uni-duesseldorf.de   
Principal Investigator: Christian Heiss, MD         
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

No publications provided

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
Study First Received: February 24, 2013
Last Updated: August 18, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
flavanols
diet
endothelial function
blood pressure
FLAVIOLA

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014