FLAVIOLA Health Study (FHS)

This study has been completed.

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: February 1, 2015

Last verified: February 2015

History of Changes

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:	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


Ages Eligible for Study:	35 Years to 60 Years (Adult)
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

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):

Sansone R, Rodriguez-Mateos A, Heuel J, Falk D, Schuler D, Wagstaff R, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M, Heiss C; Flaviola Consortium, European Union 7th Framework Program. Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015 Oct 28;114(8):1246-55. doi: 10.1017/S0007114515002822. Epub 2015 Sep 9.


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:	February 1, 2015
Health Authority:	Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:


flavanols diet endothelial function blood pressure FLAVIOLA

Additional relevant MeSH terms:


Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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