NCT02116517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
Last Updated

April 17, 2014

Status Verified

December 1, 2013

Enrollment Period

2.2 years

First QC Date

April 4, 2014

Last Update Submit

April 15, 2014

Conditions

ObeseHyperlipidemia

Keywords

obese womenhigh LDL-C

Outcome Measures

Primary Outcomes (1)

  • percentage of reduction of LDL-C

    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

    6 weeks of treatment

Secondary Outcomes (1)

  • HDL-C

    6 weeks

Study Arms (2)

green tea extract first

EXPERIMENTAL

green tea extract (EGCG) 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally cellulose 500mg tid for 6 weeks total 14 weeks

Dietary Supplement: green tea extractDietary Supplement: Placebo

Placebo first

PLACEBO COMPARATOR

cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks

Dietary Supplement: green tea extractDietary Supplement: Placebo

Interventions

green tea extractDIETARY_SUPPLEMENT

500 mg three times per day

Also known as: EGCG
Placebo firstgreen tea extract first
PlaceboDIETARY_SUPPLEMENT

cellulose 500mg three times a day for 6 weeks

Also known as: cellulose
Placebo firstgreen tea extract first

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taipei, 886, Taiwan

Location

Related Publications (4)

  • Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014.

    PMID: 24614112BACKGROUND

  • Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.

    PMID: 21649457BACKGROUND

  • Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.

    PMID: 18468736BACKGROUND

  • Huang LH, Liu CY, Wang LY, Huang CJ, Hsu CH. Effects of green tea extract on overweight and obese women with high levels of low density-lipoprotein-cholesterol (LDL-C): a randomised, double-blind, and cross-over placebo-controlled clinical trial. BMC Complement Altern Med. 2018 Nov 6;18(1):294. doi: 10.1186/s12906-018-2355-x.

    PMID: 30400924DERIVED

MeSH Terms

Conditions

ObesityHyperlipidemias

Interventions

TeaCellulose

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Chung-Hua Hsu, PhD, MD

    Taipei City Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 17, 2014

Study Start

August 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2014

Record last verified: 2013-12

Locations

TW(1)