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

NCT ID: NCT02116517

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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

Conditions

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Obese Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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green tea extract first

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

Group Type EXPERIMENTAL

green tea extract

Intervention Type DIETARY_SUPPLEMENT

500 mg three times per day

Placebo

Intervention Type DIETARY_SUPPLEMENT

cellulose 500mg three times a day for 6 weeks

Placebo first

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

Group Type PLACEBO_COMPARATOR

green tea extract

Intervention Type DIETARY_SUPPLEMENT

500 mg three times per day

Placebo

Intervention Type DIETARY_SUPPLEMENT

cellulose 500mg three times a day for 6 weeks

Interventions

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green tea extract

500 mg three times per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

cellulose 500mg three times a day for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EGCG cellulose

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Chung-Hua Hsu

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chung-Hua Hsu, PhD, MD

Role: STUDY_CHAIR

Taipei City Hospital

Locations

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Taipei City Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 24614112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21649457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18468736 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30400924 (View on PubMed)

Other Identifiers

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100WFA2200449

Identifier Type: -

Identifier Source: org_study_id

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