Anthocyanin Dose-escalation Study in Healthy Young Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Anthocyanin

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shaoguan, Guangdong, China, 512005
      • Shaoguan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Intake of placebo capsules	Dietary supplement: Placebo; Placebo capsules
Active Comparator: 20 mg; Daily intake of 20 mg anthocyanin	Dietary supplement: Anthocyanin; Capsules with different anthocyanin content
Active Comparator: 40 mg; Daily intake of 40 mg anthocyanin	Dietary supplement: Anthocyanin; Capsules with different anthocyanin content
Active Comparator: 80 mg; Daily intake of 80 mg anthocyanin	Dietary supplement: Anthocyanin; Capsules with different anthocyanin content
Active Comparator: 160 mg; Daily intake of 160 mg anthocyanin	Dietary supplement: Anthocyanin; Capsules with different anthocyanin content
Active Comparator: 320 mg; Daily intake of 320 mg anthocyanin	Dietary supplement: Anthocyanin; Capsules with different anthocyanin content

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shaoguan University
• Collaborators: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Antioxidants; Randomized Controlled Trial; Anthocyanin
• Other Study ID Numbers: SGU-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED