Brief Summary

Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their health-promoting properties, such as reducing lipid accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear need for advancing understanding with regard to effective amounts of intake for these phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of anthocyanin in healthy volunteers.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

122

participants targeted

Target at P75+ for not_applicable healthy

Timeline

Completed

Started Feb 2016

Typical duration for not_applicable healthy

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

February 1, 2016

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed

20 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed

Last Updated

March 25, 2019

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

April 13, 2016

Last Update Submit

March 21, 2019

Conditions

Healthy

Keywords

Randomized Controlled TrialAnthocyaninAntioxidants

Outcome Measures

Primary Outcomes (3)

Plasma total antioxidant capacity
Oxidative stress
2 weeks
Plasma malondialdehyde concentrations
Oxidative stress
2 weeks
Plasma 8-iso-prostaglandin concentrations
Oxidative stress
2 weeks

Secondary Outcomes (2)

Plasma tumor necrosis factor alpha concentrations
2 weeks
Plasma interleukin-6 concentrations
2 weeks

Study Arms (6)

Control

PLACEBO COMPARATOR

Intake of placebo capsules

Dietary Supplement: Placebo