Antioxidative Effect of Plantago Asiatica L. Extract

Ewha Womans University

Status: Completed

Conditions: Oxidative Stress

Treatments: Dietary Supplement: Plantago asiatica L. extract 5g; Dietary Supplement: Plantago asiatica L. extract 20g; Dietary Supplement: Placebo; Dietary Supplement: Plantago asiatica L. extract 10g

Study type: Interventional

Funder types: Other

Identifiers

NCT01278589

PLA_Biofood

Details and patient eligibility

About

The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.

Full description

The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.

Enrollment: 40 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults age over 30
• BMI(Body mass index) between 25 and 33 kg/m2
• Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL

Exclusion criteria

• Subject who has taken part in other clinical trials within 30 days of screening visit
• Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
• Subject who is pregnant or breast feeding
• Subject who lost body weight over 4kg within 30days of screening visit
• Alcoholic
• Smoker
• Subject who takes excessive exercise (over 7hours/week)
• Subject who has hypertension(≥140/90mmHg), diabetes(fasting blood glucose ≥126mg/dL), kidney disease, hepatic disease or hyperthyroidism within 2years
• Subject who has an allergy to the ingredients of study product

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

• Plantago asiatica L. extract 5g

Experimental group

Treatment:

Dietary Supplement: Plantago asiatica L. extract 5g

Plantago asiatica L. extract 10g

Experimental group

Treatment:

Dietary Supplement: Plantago asiatica L. extract 10g

Plantago asiatica L. extract 20g

Experimental group

Treatment:

Dietary Supplement: Plantago asiatica L. extract 20g

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo