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

NCT ID: NCT03118791

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double blind randomized controlled crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Capsules containing maltodextrin

Group Type PLACEBO_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

80 mg ACN

Capsules containing 80 mg anthocyanins

Group Type ACTIVE_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

160 mg ACN

Capsules containing 160 mg anthocyanins

Group Type ACTIVE_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

240 mg ACN

Capsules containing 240 mg anthocyanins

Group Type ACTIVE_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

320 mg ACN

Capsules containing 320 mg anthocyanins

Group Type ACTIVE_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

480 mg ACN

Capsules containing 480 mg anthocyanins

Group Type ACTIVE_COMPARATOR

anthocyanins

Intervention Type DIETARY_SUPPLEMENT

Acute intake of capsules

Interventions

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anthocyanins

Acute intake of capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ACND

Identifier Type: -

Identifier Source: org_study_id