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Clinical Trials/NCT02116517
NCT02116517CompletedPhase 3

Phase 3 Study; Effects of Green Tea Extract on Obese Women With High Level of Low Density Lipoprotein (LDL): a Randomized, Double-blinded, and Cross-over Placebo-controlled Clinical Trial

National Yang Ming Chiao Tung University2 sites in 1 country73 target enrollmentStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
73
Locations
2
Primary Endpoint
percentage of reduction of LDL-C
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Green tea is one of the most popular beverages in the world. It is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese with high LDL level.

Detailed Description

Randomized, double-blind, crossover placebo-controlled clinical trial

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •age between 18 and 65 years
  • •body mass index (BMI) >= 27 kg/m2
  • •fasting low-density-lipoprotein cholesterol (LDL) >= 130mg/dl and (4) willing to participate in this trial.

Exclusion Criteria

  • •serum alanine transaminase > 80 U/L
  • •serum creatinine > 1.8 mg/dl
  • •breast feeding or pregnancy
  • •heart failure, acute myocardial infarction, stroke, heavy injury
  • •any other conditions not suitable for trial as evaluated by the physician. -

Outcomes

Primary Outcomes

percentage of reduction of LDL-C

Time Frame: 6 weeks of treatment

level of LDL-C before intervention minus level of LDL-C after intervention equal to reduction of LDL-C, percentage of reduction of LDL-C equal to the level of reduction of LDL-C divided by level of LDL-C before intervention

Secondary Outcomes

  • HDL-C(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chung-Hua Hsu

Dr

National Yang Ming Chiao Tung University

Study Sites (2)

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