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Completed

NCT Number: NCT01799005

FLAVIOLA Health Study

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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Key information

Conditions

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flavanol (410 mg)

Dietary Supplement

Other names: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days

Control (no flavanols)

Dietary Supplement

Other names: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day

Primary outcomes

  1. Endothelial function

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

Secondary outcomes

  1. Blood pressure

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

  2. Glucose

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

  3. Plasma lipids

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

Other outcomes

  1. Flavanol metabolites

    Time frame: day 0 [baseline], and day 30 each 0 and 2h

  2. Microparticles

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

  3. Dietary pattern

    Time frame: Time points: day 0 [baseline] and day 30

  4. Vascular stiffness

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

  5. Microvascular function

    Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Acronym: FHS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2013
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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