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

Not Applicable

Completed

• Conditions: Healthy Men
• Interventions: Dietary Supplement: anthocyanins

• Registration Number: NCT03118791
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-04-07
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Primary Completion: 2017-08-08
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
80 mg ACN	anthocyanins	Capsules containing 80 mg anthocyanins
240 mg ACN	anthocyanins	Capsules containing 240 mg anthocyanins
320 mg ACN	anthocyanins	Capsules containing 320 mg anthocyanins
160 mg ACN	anthocyanins	Capsules containing 160 mg anthocyanins
480 mg ACN	anthocyanins	Capsules containing 480 mg anthocyanins
Placebo	anthocyanins	Capsules containing maltodextrin

Primary Outcome Measures

Name	Time	Method
Endothelial function	Changes from baseline to 2 hours postconsumption	Flow-mediated dilation

Secondary Outcome Measures

Name	Time	Method
Blood pressure	0 and 2 hours postconsumption	Automatic measurements

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany