Anthocyanin Dose-escalation Study in Healthy Young Adults

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Anthocyanin; Dietary Supplement: Placebo

• Registration Number: NCT02760511
• Lead Sponsor: Shaoguan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-03
• Primary Completion: 2016-09-01
• Study Completion: 2017-05-01
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 mg	Anthocyanin	Daily intake of 40 mg anthocyanin
160 mg	Anthocyanin	Daily intake of 160 mg anthocyanin
80 mg	Anthocyanin	Daily intake of 80 mg anthocyanin
320 mg	Anthocyanin	Daily intake of 320 mg anthocyanin
Control	Placebo	Intake of placebo capsules
20 mg	Anthocyanin	Daily intake of 20 mg anthocyanin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma tumor necrosis factor alpha concentrations	2 weeks	Inflammatory response
Plasma interleukin-6 concentrations	2 weeks	Inflammatory response

Trial Locations

Locations (1)

Shaoguan University; 🇨🇳 Shaoguan, Guangdong, China