An interventional study of Flavanol (410 mg) and Control (no flavanols) in Vascular Health, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-03.
Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Prevention
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.
Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ingestion of 410mg flavanols twice a day for 30 days
Dietary Supplement: Flavanol (410 mg)
Ingestion of a macro and micro nutrients matched flavanol free drink
Dietary Supplement: Control (no flavanols)
Also known as: Ingestion of intervention drink containing 410 mg flavanols twice a day for 30 days
Also known as: Ingestion of a macro- and micronutrient matched control drink that is free of flavanols twice per day
Endothelial function
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
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.
Flavanol metabolites
Time frame: day 0 [baseline], and day 30 each 0 and 2h
Microparticles
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Dietary pattern
Time frame: Time points: day 0 [baseline] and day 30
Vascular stiffness
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
Microvascular function
Time frame: Time points: day 0 [baseline], and day 30 each 0 and 2h.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf