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

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Post-menopausal Women

Treatments: Dietary Supplement: placebo capsules; Dietary Supplement: Anthocyanin capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02517801

Anthocyanins

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Anthocyanin capsules

Experimental group

Description:

Chronic intake of 2 capsules for 30 days (2x daily)

Treatment:

Dietary Supplement: Anthocyanin capsules

placebo capsules

Placebo Comparator group

Description:

Chronic intake of 2 capsules for 30 days (2x daily)

Treatment:

Dietary Supplement: placebo capsules