Anthocyanin Dose-escalation Study in Healthy Young Adults

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Anthocyanin
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Intake of placebo capsules | Dietary Supplement: Placebo<br>* Placebo capsules<br>|
| Active Comparator: 20 mg<br>Daily intake of 20 mg anthocyanin | Dietary Supplement: Anthocyanin<br>* Capsules with different anthocyanin content<br>|
| Active Comparator: 40 mg<br>Daily intake of 40 mg anthocyanin | Dietary Supplement: Anthocyanin<br>* Capsules with different anthocyanin content<br>|
| Active Comparator: 80 mg<br>Daily intake of 80 mg anthocyanin | Dietary Supplement: Anthocyanin<br>* Capsules with different anthocyanin content<br>|
| Active Comparator: 160 mg<br>Daily intake of 160 mg anthocyanin | Dietary Supplement: Anthocyanin<br>* Capsules with different anthocyanin content<br>|
| Active Comparator: 320 mg<br>Daily intake of 320 mg anthocyanin | Dietary Supplement: Anthocyanin<br>* Capsules with different anthocyanin content<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Anthocyanin, Antioxidants