Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Healthy Men

Treatments: Dietary Supplement: anthocyanins

Study type: Interventional

Funder types: Other

Identifiers

NCT03118791

ACND

Details and patient eligibility

About

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.

Full description

Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. A double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. On 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be performed. The aim is to investigate whether purified anthocyanins are able to increase FMD at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men aged 18-45 years old
• Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study
• able to give signed written informed consent
• signed written infomred consent form
• healthy male subjects (no clinical signs or symptoms of CVD.

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: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

10 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Capsules containing maltodextrin

Treatment:

Dietary Supplement: anthocyanins

80 mg ACN

Active Comparator group

Description:

Capsules containing 80 mg anthocyanins

Treatment:

Dietary Supplement: anthocyanins

160 mg ACN

Active Comparator group

Description:

Capsules containing 160 mg anthocyanins

Treatment:

Dietary Supplement: anthocyanins

240 mg ACN

Active Comparator group

Description:

Capsules containing 240 mg anthocyanins

Treatment:

Dietary Supplement: anthocyanins

320 mg ACN

Active Comparator group

Description:

Capsules containing 320 mg anthocyanins

Treatment:

Dietary Supplement: anthocyanins

480 mg ACN

Active Comparator group

Description:

Capsules containing 480 mg anthocyanins

Treatment:

Dietary Supplement: anthocyanins