Effect of Green Tea in Obese Pre-hypertensive Women

NCT ID: NCT01861171

Last Updated: 2013-05-23

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the effects of green tea on body weight, waist circumference, metabolic profile, inflammation, blood pressure and endothelial function in obese pre-hypertensive women.

Detailed Description

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Crossover randomized controlled double-blinded trial. Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments. Endothelial function was evaluated by peripheral arterial tonometry method, using Endo-PAT 2000®.

Conditions

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Obese Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Crossover randomized controlled double-blinded trial. Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.

Group Type PLACEBO_COMPARATOR

Green Tea

Intervention Type DIETARY_SUPPLEMENT

Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.

Green Tea

Crossover randomized controlled double-blinded trial. Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.

Group Type ACTIVE_COMPARATOR

Green Tea

Intervention Type DIETARY_SUPPLEMENT

Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.

Interventions

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Green Tea

Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

pre-hypertensive women obese adult

Exclusion Criteria

pregnant smoker elderly
Minimum Eligible Age

28 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Felipe Sanjuliani

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lívia P Nogueira

Role: PRINCIPAL_INVESTIGATOR

Pedro Ernesto Universitary Hospital

Locations

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Pedro Ernesto Hospital Universitary

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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clinex01

Identifier Type: -

Identifier Source: org_study_id

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