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Completed

NCT Number: NCT02760511

Anthocyanin Dose-escalation Study in Healthy Young Adults

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.

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Key information

Conditions

Healthy

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaoguan University

Shaoguan, Guangdong, 512005, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anthocyanin

Dietary Supplement

Capsules with different anthocyanin content

Placebo

Dietary Supplement

Placebo capsules

Primary outcomes

  1. Plasma total antioxidant capacity

    Time frame: 2 weeks

    Oxidative stress

  2. Plasma malondialdehyde concentrations

    Time frame: 2 weeks

    Oxidative stress

  3. Plasma 8-iso-prostaglandin concentrations

    Time frame: 2 weeks

    Oxidative stress

Secondary outcomes

  1. Plasma tumor necrosis factor alpha concentrations

    Time frame: 2 weeks

    Inflammatory response

  2. Plasma interleukin-6 concentrations

    Time frame: 2 weeks

    Inflammatory response

Sponsors and collaborators

Lead sponsor

Shaoguan University

Other

Collaborators

  • Sun Yat-sen University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 3, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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