Anthocyanin Dose-escalation Study in Healthy Young Adults

NCT ID: NCT02760511

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-05-01

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Intake of placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules

20 mg

Daily intake of 20 mg anthocyanin

Group Type ACTIVE_COMPARATOR

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Capsules with different anthocyanin content

40 mg

Daily intake of 40 mg anthocyanin

Group Type ACTIVE_COMPARATOR

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Capsules with different anthocyanin content

80 mg

Daily intake of 80 mg anthocyanin

Group Type ACTIVE_COMPARATOR

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Capsules with different anthocyanin content

160 mg

Daily intake of 160 mg anthocyanin

Group Type ACTIVE_COMPARATOR

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Capsules with different anthocyanin content

320 mg

Daily intake of 320 mg anthocyanin

Group Type ACTIVE_COMPARATOR

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

Capsules with different anthocyanin content

Interventions

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Anthocyanin

Capsules with different anthocyanin content

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Shaoguan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shaoguan University

Shaoguan, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SGU-04

Identifier Type: -

Identifier Source: org_study_id

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