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Antioxidative Effect of Plantago Asiatica L. Extract

Ewha Womans University logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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