FLAVIOLA Health Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-08-31

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.

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Detailed Description

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Conditions

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Vascular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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flavanol rich intervention

Ingestion of 410mg flavanols twice a day for 30 days

Group Type ACTIVE_COMPARATOR

Flavanol (410 mg)

Intervention Type DIETARY_SUPPLEMENT

flavanol free intervention

Ingestion of a macro and micro nutrients matched flavanol free drink

Group Type PLACEBO_COMPARATOR

Control (no flavanols)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Flavanol (410 mg)

Intervention Type DIETARY_SUPPLEMENT

Control (no flavanols)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day

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)

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes