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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03118791
Other study ID # ACND
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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