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

Healthy Men Clinical Trial

Official title:

Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118791
• Other study ID #: ACND
• Status: Completed
• Phase: N/A
• First received: April 7, 2017
• Last updated: November 8, 2017
• Start date: April 7, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 31, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Men

Intervention

Dietary Supplement:
• anthocyanins
Acute intake of capsules

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other Pre-specified Outcome Measures	Plasma (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS)	0 and 2 hours postconsumption
Primary	Endothelial function	Flow-mediated dilation	Changes from baseline to 2 hours postconsumption
Secondary	Blood pressure	Automatic measurements	0 and 2 hours postconsumption