Anthocyanin Dose-escalation Study in Healthy Young Adults

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760511

Enrollment

122

Registered

2016-05-03

Start date

2016-02-01

Completion date

2017-05-01

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Randomized Controlled Trial, Anthocyanin, Antioxidants

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.

Interventions

DIETARY_SUPPLEMENTAnthocyanin

Capsules with different anthocyanin content

DIETARY_SUPPLEMENTPlacebo

Placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* Blood test, liver function test, renal function test are normal; * Blood lipids, cardiac function are normal; * 18.5\<BMI\<23.9; * Regular dietary, seldomly eating outside; * Stable condition of body weight in recent 3 months

Exclusion criteria

* \> 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.

Design outcomes

Primary

Measure	Time frame	Description
Plasma total antioxidant capacity	2 weeks	Oxidative stress
Plasma malondialdehyde concentrations	2 weeks	Oxidative stress
Plasma 8-iso-prostaglandin concentrations	2 weeks	Oxidative stress

Secondary

Measure	Time frame	Description
Plasma tumor necrosis factor alpha concentrations	2 weeks	Inflammatory response
Plasma interleukin-6 concentrations	2 weeks	Inflammatory response

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026