FLAVIOLA Health Study (FHS)
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ClinicalTrials.gov Identifier: NCT01799005 |
Recruitment Status :
Completed
First Posted : February 26, 2013
Last Update Posted : February 3, 2015
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Condition or disease | Intervention/treatment | Phase |
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Vascular Health | Dietary Supplement: Flavanol (410 mg) Dietary Supplement: Control (no flavanols) | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: flavanol rich intervention
Ingestion of 410mg flavanols twice a day for 30 days
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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
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Dietary Supplement: Control (no flavanols)
Other Name: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day |
- Endothelial function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ]
- 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. ]
- 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. ]

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

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
Germany | |
Division of Cardiology, Pulmonology and Vascular Medicine | |
Duesseldorf, NRW, Germany, 40225 |
Principal Investigator: | Christian Heiss, MD | Division of Cardiology, Pulmonology and Vascular Medicine | |
Study Chair: | Malte Kelm, MD | Division of Cardiology, Pulmonology and Vascular Medicine |
Responsible Party: | Klinik für Kardiologie, Pneumologie und Angiologie, PD Dr. med. Christian Heiss, Heinrich-Heine University, Duesseldorf |
ClinicalTrials.gov Identifier: | NCT01799005 |
Other Study ID Numbers: |
FHS |
First Posted: | February 26, 2013 Key Record Dates |
Last Update Posted: | February 3, 2015 |
Last Verified: | February 2015 |
flavanols diet endothelial function blood pressure FLAVIOLA |
Micronutrients Physiological Effects of Drugs |