Anthocyanin Dose-escalation Study in Healthy Young Adults

Shaoguan University

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Anthocyanin

Study type: Interventional

Funder types: Other

Identifiers

NCT02760511

SGU-04

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 6 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Intake of placebo capsules

Treatment:

Dietary Supplement: Placebo

20 mg

Active Comparator group

Description:

Daily intake of 20 mg anthocyanin

Treatment:

Dietary Supplement: Anthocyanin

40 mg

Active Comparator group

Description:

Daily intake of 40 mg anthocyanin

Treatment:

Dietary Supplement: Anthocyanin

80 mg

Active Comparator group

Description:

Daily intake of 80 mg anthocyanin

Treatment:

Dietary Supplement: Anthocyanin

160 mg

Active Comparator group

Description:

Daily intake of 160 mg anthocyanin

Treatment:

Dietary Supplement: Anthocyanin

320 mg

Active Comparator group

Description:

Daily intake of 320 mg anthocyanin

Treatment:

Dietary Supplement: Anthocyanin