Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women

Study Overview
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Brief Summary
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Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. The investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male volunteers. There were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. A large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. Whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.

Official Title
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Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women

Conditions
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Post-menopausal Women

Intervention / Treatment
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* Dietary Supplement: Anthocyanin capsules
* Dietary Supplement: placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis > 50 years Exclusion Criteria: cardiovascular disease acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) diabetes mellitus C-reactive protein > 0.5 mg/dL malignant disease hypotension (≤100 / 60 mm Hg)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anthocyanin capsules<br>Chronic intake of 2 capsules for 30 days (2x daily) | Dietary Supplement: Anthocyanin capsules<br>* Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.<br>|
| Placebo Comparator: placebo capsules<br>Chronic intake of 2 capsules for 30 days (2x daily) | Dietary Supplement: placebo capsules<br>* Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption | Baseline and on day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity | measured by SphygmoCor at 0 and 2 hours postconsumption | Baseline and on day 30 | 
| Central blood pressure | measured by SphygmoCor at 0 and 2 hours postconsumption | Baseline and on day 30 | 
| Heart rate | measured by SphygmoCor at 0 and 2 hours postconsumption | Baseline and on day 30 | 
| Ambulatory blood pressure | measured by Tonoport V , 24 h continuous measurement postconsumption | Baseline and on day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, vascular function, anthocyanins, Post-menopausal women