FLAVIOLA Health Study

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

Conditions
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Vascular Health

Intervention / Treatment
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* Dietary Supplement: Flavanol (410 mg)
* Dietary Supplement: Control (no flavanols)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavanol rich intervention<br>Ingestion of 410mg flavanols twice a day for 30 days | Dietary Supplement: Flavanol (410 mg)<br> <br> * Other names: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days;|
| Placebo Comparator: flavanol free intervention<br>Ingestion of a macro and micro nutrients matched flavanol free drink | Dietary Supplement: Control (no flavanols)<br> <br> * Other names: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | Time points: day 0 [baseline], and day 30 each 0 and 2h. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Time points: day 0 [baseline], and day 30 each 0 and 2h. | 
| Glucose |  | Time points: day 0 [baseline], and day 30 each 0 and 2h. | 
| Plasma lipids |  | Time points: day 0 [baseline], and day 30 each 0 and 2h. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavanols, diet, endothelial function, blood pressure, FLAVIOLA