Effect of Green Tea in Obese Pre-hypertensive Women
Effect of Green Tea on Adiposity, Metabolic Profile, Blood Pressure and Endothelial Function in Obese Pre-hypertensive Women
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
Typical duration for not_applicable
1 active site
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
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedMay 23, 2013
May 1, 2013
1.9 years
May 21, 2013
May 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of blood pressure
12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORCrossover 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.
Green Tea
ACTIVE COMPARATORCrossover 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- pre-hypertensive women obese adult
You may not qualify if:
- pregnant smoker elderly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pedro Ernesto Hospital Universitary
Rio de Janeiro, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lívia P Nogueira
Pedro Ernesto Universitary Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
July 1, 2010
Primary Completion
June 1, 2012
Study Completion
September 1, 2012
Last Updated
May 23, 2013
Record last verified: 2013-05