Completed

Anthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial

What is being tested

Anthocyanin

+ Placebo

Dietary Supplement

Who is being recruted

From 18 to 25 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled

Interventional

Study Start: February 2016

See protocol details

Summary

Principal SponsorShaoguan University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleAnthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial

NCT02760511

Principal SponsorShaoguan University

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 25 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

Regular dietary, seldomly eating outside;

Blood test, liver function test, renal function test are normal;

Blood lipids, cardiac function are normal;

18.5<BMI<23.9;

Show More Criteria

3 exclusion criteria prevent from participating

140 grams of alcohol/week for male and >70 grams of alcohol/week for female, smoking regularly;

Known diagnosis of acute diseases or chronic diseases in recent 1 month;

Be planning to be pregnant in a year, or being pregnant and lactation.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

16.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Daily intake of 160 mg anthocyanin

Group II

Active Comparator

Daily intake of 20 mg anthocyanin

Group III

Active Comparator

Daily intake of 320 mg anthocyanin

Group IV

Active Comparator

Daily intake of 40 mg anthocyanin

Group 5

Active Comparator

Daily intake of 80 mg anthocyanin

Group 6

Placebo

Intake of placebo capsules

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shaoguan University

Shaoguan, ChinaOpen Shaoguan University in Google Maps

CompletedOne Study Center