FLAVIOLA Health Study (FHS)
This study has been completed.
Sponsor:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01799005
First received: February 24, 2013
Last updated: February 1, 2015
Last verified: February 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Vascular Health |
Dietary Supplement: Flavanol (410 mg) Dietary Supplement: Control (no flavanols) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study |
Further study details as provided by Heinrich-Heine University, Duesseldorf:
Primary Outcome Measures:
- Endothelial function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
- Glucose [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
- Plasma lipids [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: Yes ]
Other Outcome Measures:
- Flavanol metabolites [ Time Frame: day 0 [baseline], and day 30 each 0 and 2h ] [ Designated as safety issue: No ]
- Microparticles [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
- Dietary pattern [ Time Frame: Time points: day 0 [baseline] and day 30 ] [ Designated as safety issue: No ]
- Vascular stiffness [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
- Microvascular function [ Time Frame: Time points: day 0 [baseline], and day 30 each 0 and 2h. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2013 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: flavanol rich intervention
Ingestion of 410mg flavanols twice a day for 30 days
|
Dietary Supplement: Flavanol (410 mg)
Other Name: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
|
|
Placebo Comparator: flavanol free intervention
Ingestion of a macro and micro nutrients matched flavanol free drink
|
Dietary Supplement: Control (no flavanols)
Other Name: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
|
Eligibility| Ages Eligible for Study: | 35 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799005
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799005
Locations
| Germany | |
| Division of Cardiology, Pulmonology and Vascular Medicine | |
| Duesseldorf, NRW, Germany, 40225 | |
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
| Principal Investigator: | Christian Heiss, MD | Division of Cardiology, Pulmonology and Vascular Medicine | |
| Study Chair: | Malte Kelm, MD | Division of Cardiology, Pulmonology and Vascular Medicine |
More Information
No publications provided
| Responsible Party: | Klinik für Kardiologie, Pneumologie und Angiologie, PD Dr. med. Christian Heiss, Heinrich-Heine University, Duesseldorf |
| ClinicalTrials.gov Identifier: | NCT01799005 History of Changes |
| Other Study ID Numbers: | FHS |
| Study First Received: | February 24, 2013 |
| Last Updated: | February 1, 2015 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Heinrich-Heine University, Duesseldorf:
|
flavanols diet endothelial function blood pressure FLAVIOLA |
ClinicalTrials.gov processed this record on February 27, 2015