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

• ClinicalTrials.gov Identifier: NCT03118791
• Recruitment Status: Completed
• First Posted: April 18, 2017
• Last Update Posted: November 9, 2017
• Sponsor: Heinrich-Heine University, Duesseldorf
• Information provided by (Responsible Party): Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Men	Dietary Supplement: anthocyanins	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Double blind randomized controlled crossover
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function
• Actual Study Start Date: April 7, 2017
• Actual Primary Completion Date: August 8, 2017
• Actual Study Completion Date: October 31, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Capsules containing maltodextrin	Dietary Supplement: anthocyanins; Acute intake of capsules
Active Comparator: 80 mg ACN; Capsules containing 80 mg anthocyanins	Dietary Supplement: anthocyanins; Acute intake of capsules
Active Comparator: 160 mg ACN; Capsules containing 160 mg anthocyanins	Dietary Supplement: anthocyanins; Acute intake of capsules
Active Comparator: 240 mg ACN; Capsules containing 240 mg anthocyanins	Dietary Supplement: anthocyanins; Acute intake of capsules
Active Comparator: 320 mg ACN; Capsules containing 320 mg anthocyanins	Dietary Supplement: anthocyanins; Acute intake of capsules
Active Comparator: 480 mg ACN; Capsules containing 480 mg anthocyanins	Dietary Supplement: anthocyanins; Acute intake of capsules

Outcome Measures

Primary Outcome Measures :

1. Endothelial function [ Time Frame: Changes from baseline to 2 hours postconsumption ]
   Flow-mediated dilation

Secondary Outcome Measures :

1. Blood pressure [ Time Frame: 0 and 2 hours postconsumption ]
   Automatic measurements

Other Outcome Measures:

1. Other Pre-specified Outcome Measures [ Time Frame: 0 and 2 hours postconsumption ]
   Plasma (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

Germany

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Duesseldorf, Germany, 40225

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

More Information

• Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principal Investigator, Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT03118791
• Other Study ID Numbers: ACND
• First Posted: April 18, 2017
• Last Update Posted: November 9, 2017
• Last Verified: November 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No