FLAVIOLA Health Study (FHS)

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Vascular Health

Treatments: Dietary Supplement: Flavanol (410 mg); Dietary Supplement: Control (no flavanols)

Study type: Interventional

Funder types: Other

Identifiers

NCT01799005

FHS

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

flavanol rich intervention

Active Comparator group

Description:

Ingestion of 410mg flavanols twice a day for 30 days

Treatment:

Dietary Supplement: Flavanol (410 mg)

flavanol free intervention

Placebo Comparator group

Description:

Ingestion of a macro and micro nutrients matched flavanol free drink

Treatment:

Dietary Supplement: Control (no flavanols)