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

NCT03118791 | Completed

• 1 other identifier: ACND
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Flow-mediated dilation

  Changes from baseline to 2 hours postconsumption

Secondary Outcomes (1)

• Blood pressure

  0 and 2 hours postconsumption

Other Outcomes (1)

• Other Pre-specified Outcome Measures

  0 and 2 hours postconsumption

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Capsules containing maltodextrin

Dietary Supplement: anthocyanins

80 mg ACN

ACTIVE COMPARATOR

Capsules containing 80 mg anthocyanins

Dietary Supplement: anthocyanins

160 mg ACN

ACTIVE COMPARATOR

Capsules containing 160 mg anthocyanins

Dietary Supplement: anthocyanins

240 mg ACN

ACTIVE COMPARATOR

Capsules containing 240 mg anthocyanins

Dietary Supplement: anthocyanins

320 mg ACN

ACTIVE COMPARATOR

Capsules containing 320 mg anthocyanins

Dietary Supplement: anthocyanins

480 mg ACN

ACTIVE COMPARATOR

Capsules containing 480 mg anthocyanins

Dietary Supplement: anthocyanins

Interventions

anthocyanins DIETARY_SUPPLEMENT

Acute intake of capsules

160 mg ACN; 240 mg ACN; 320 mg ACN; 480 mg ACN; 80 mg ACN; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

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

Düsseldorf, 40225, Germany

Location

MeSH Terms

Interventions

Anthocyanins

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind randomized controlled crossover

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 18, 2017
• Study Start: April 7, 2017
• Primary Completion: August 8, 2017
• Study Completion: October 31, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

DE (1)