NCT01799005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

February 24, 2013

Last Update Submit

February 1, 2015

Conditions

Vascular Health

Keywords

flavanolsdietendothelial functionblood pressureFLAVIOLA

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

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

Secondary Outcomes (3)

  • 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.

Other Outcomes (5)

  • Flavanol metabolites

    day 0 [baseline], and day 30 each 0 and 2h

  • Microparticles

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

  • Dietary pattern

    Time points: day 0 [baseline] and day 30

  • +2 more other outcomes

Study Arms (2)

flavanol rich intervention

ACTIVE COMPARATOR

Ingestion of 410mg flavanols twice a day for 30 days

Dietary Supplement: Flavanol (410 mg)

flavanol free intervention

PLACEBO COMPARATOR

Ingestion of a macro and micro nutrients matched flavanol free drink

Dietary Supplement: Control (no flavanols)

Interventions

Flavanol (410 mg)DIETARY_SUPPLEMENT
Also known as: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
flavanol rich intervention
Control (no flavanols)DIETARY_SUPPLEMENT
Also known as: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
flavanol free intervention

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male, age 35-60 years, healthy
  • female, age 35-60 years, healthy

You may not qualify if:

  • diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (1)

  • Sansone R, Rodriguez-Mateos A, Heuel J, Falk D, Schuler D, Wagstaff R, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M, Heiss C; Flaviola Consortium, European Union 7th Framework Program. Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015 Oct 28;114(8):1246-55. doi: 10.1017/S0007114515002822. Epub 2015 Sep 9.

    PMID: 26348767DERIVED

Study Officials

  • Christian Heiss, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

  • Malte Kelm, MD

    Division of Cardiology, Pulmonology and Vascular Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. Christian Heiss

Study Record Dates

First Submitted

February 24, 2013

First Posted

February 26, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

DE(1)