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Effects of Green Tea Extract on Obese Women With High Level of LDL

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02116517
Acronym
GTE-LDL
Enrollment
73
Registered
2014-04-17
Start date
2011-08-31
Completion date
2013-12-31
Last updated
2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Obese

Keywords

obese women, high LDL-C

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

Interventions

DIETARY_SUPPLEMENTgreen tea extract

500 mg three times per day

DIETARY_SUPPLEMENTPlacebo

cellulose 500mg three times a day for 6 weeks

Sponsors

Taipei City Hospital
CollaboratorOTHER_GOV
National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. age between 18 and 65 years 2. body mass index (BMI) \>= 27 kg/m2 3. fasting low-density-lipoprotein cholesterol (LDL) \>= 130mg/dl and (4) willing to participate in this trial.

Exclusion criteria

1. serum alanine transaminase \> 80 U/L 2. serum creatinine \> 1.8 mg/dl 3. breast feeding or pregnancy 4. heart failure, acute myocardial infarction, stroke, heavy injury 5. any other conditions not suitable for trial as evaluated by the physician. -

Design outcomes

Primary

MeasureTime frameDescription
percentage of reduction of LDL-C6 weeks of treatmentlevel 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

MeasureTime frameDescription
HDL-C6 weeksserum level of high density lipoprotein cholesterol

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026