FLAVIOLA Health Study

Vascular Health Clinical Trial

— FHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799005
• Other study ID #: FHS
• Status: Completed
• Phase: N/A
• First received: February 24, 2013
• Last updated: February 1, 2015
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vascular Health

Intervention

Dietary Supplement:
• Flavanol (410 mg)

• Control (no flavanols)

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonology and Vascular Medicine	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Flavanol metabolites		day 0 [baseline], and day 30 each 0 and 2h	No
Other	Microparticles		Time points: day 0 [baseline], and day 30 each 0 and 2h.	No
Other	Dietary pattern		Time points: day 0 [baseline] and day 30	No
Other	Vascular stiffness		Time points: day 0 [baseline], and day 30 each 0 and 2h.	No
Other	Microvascular function		Time points: day 0 [baseline], and day 30 each 0 and 2h.	No
Primary	Endothelial function		Time points: day 0 [baseline], and day 30 each 0 and 2h.	No
Secondary	Blood pressure		Time points: day 0 [baseline], and day 30 each 0 and 2h.	Yes
Secondary	Glucose		Time points: day 0 [baseline], and day 30 each 0 and 2h.	Yes
Secondary	Plasma lipids		Time points: day 0 [baseline], and day 30 each 0 and 2h.	Yes