Vascular HealthFHSNCT01799005
FLAVIOLA Health Study
A study testing Flavanol (410 mg) in people with Vascular Health, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Health
- What is being tested?
- Flavanol (410 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male, age 35-60 years, healthy
- female, age 35-60 years, healthy
Who cannot join
- diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonology and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled 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.
- Conditions
- Vascular Health
- Being tested
- Flavanol (410 mg), Control (no flavanols)
- Keywords
- flavanols, diet, endothelial function, blood pressure, FLAVIOLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol (410 mg)Dietary supplement
Also called Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
Control (no flavanols)Dietary supplement
Also called Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
| Study group | Role | What they receive |
|---|---|---|
| flavanol rich intervention | Active comparator | Ingestion of 410mg flavanols twice a day for 30 days Receives: Dietary Supplement: Flavanol (410 mg) |
| flavanol free intervention | Placebo comparator | Ingestion of a macro and micro nutrients matched flavanol free drink Receives: Dietary Supplement: Control (no flavanols) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Secondary outcomes (3)
Blood pressure
Measured: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Glucose
Measured: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Plasma lipids
Measured: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799005
- Sponsor's protocol ID
- FHS
- Acronym
- FHS
- Status last verified
- Feb 2015
- First submitted
- 24 Feb 2013
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26348767
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01799005
- Acronym / sponsor ID
- FHS / FHS
- Conditions
- Vascular Health
- Keywords
- flavanols, diet, endothelial function, blood pressure, FLAVIOLA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flavanol rich intervention | Active comparator | Dietary Supplement: Flavanol (410 mg)Ingestion of 410mg flavanols twice a day for 30 days |
| flavanol free intervention | Placebo comparator | Dietary Supplement: Control (no flavanols)Ingestion of a macro and micro nutrients matched flavanol free drink |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male, age 35-60 years, healthy
- female, age 35-60 years, healthy
Key exclusion criteria (1 listed)
- diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavanol (410 mg)Also: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days | Dietary supplement | flavanol rich intervention |
| Control (no flavanols)Also: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day | Dietary supplement | flavanol free intervention |
Primary outcome
Endothelial function
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
3 secondary outcomes
Blood pressure
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Glucose
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Plasma lipids
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Derived from this study: PubMed 26348767Sansone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavanol (410 mg) in people with Vascular Health, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.