Cardioprotective Effects of Green Tea Versus Maté Intake
Primary Purpose
Dyslipidemia, Inflammation, Obesity
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Yerba Mate Tea
Green tea
Apple tea
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Camellia sinensis, Ilex paraguariensis, Green tea, Yerba mate tea, Maté, Dyslipidemia, Inflammation, Obesity
Eligibility Criteria
Inclusion Criteria:
- age 35-60 years
- non-treated dyslipidemia (TC > 200mg/dL and/or TG > 150 mg/dL and/or HDL-c < 40 mg/dL for men and 50mg /dL for women)
- BMI 25-35 Kg/m²
Exclusion Criteria:
- use or indication for use of lipid-lowering agents and/or vitamin supplement
- non-steroids anti inflammatory use
- hormone replacement therapy
- contraceptive use
- pregnancy
- nursing
- unexplained weight loss (>2 Kg) 2 months before the study
- altered hepatic function
- those who do not sign the informed consent
Sites / Locations
- Instituto de Cardiologia / Fundação Universitária de CardiologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Yerba Mate Tea
Green Tea
Apple Tea
Arm Description
Subjects will drink 1000ml/day of yerba mate tea for 8 weeks.
Subjects will drink 1000ml/day of green tea for 8 weeks.
Subjects will drink 1000ml/day of apple tea for 8 weeks.
Outcomes
Primary Outcome Measures
Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen).
Secondary Outcome Measures
Decreases in body weight, body mass index, body fat ratio, abdominal and waist circumferences and waist to hip ratio. Changes in glucose and insulin will also be evaluated.
Full Information
NCT ID
NCT00933647
First Posted
July 6, 2009
Last Updated
July 10, 2009
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT00933647
Brief Title
Cardioprotective Effects of Green Tea Versus Maté Intake
Official Title
Effects of Yerba Mate and Green Tea Consumption on Cardiovascular Risk Factors in Dyslipidemic and Overweight Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects.
Detailed Description
Recommendations of lifestyle and dietary content changes are often made for primary prevention and improvement of many health conditions, including cardiovascular disease. For centuries, green tea (Camellia sinensis) has been linked to good health. Nowadays, it is considered a functional food because of its physiological benefits, mainly in terms of cardiovascular prevention. Green tea is considered one of the best sources of phenolic compounds, which possess antioxidant properties that may contribute to a reduction in the risk of cardiovascular disease. Lesser-known worldwide, but widely consumed in southern Latin America countries, yerba mate tea (Ilex paraguariensis) is also a good source of phenolic compounds. The antioxidant capacity of green tea has been extensively studied; however, few studies have reported that the antioxidant properties of maté tea is even greater than green tea. For this reason, the present study aims to compare the possible effects of the oral ingestion of maté and green tea on the lipid and inflammatory profiles in a southern Brazilian population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Inflammation, Obesity
Keywords
Camellia sinensis, Ilex paraguariensis, Green tea, Yerba mate tea, Maté, Dyslipidemia, Inflammation, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yerba Mate Tea
Arm Type
Experimental
Arm Description
Subjects will drink 1000ml/day of yerba mate tea for 8 weeks.
Arm Title
Green Tea
Arm Type
Active Comparator
Arm Description
Subjects will drink 1000ml/day of green tea for 8 weeks.
Arm Title
Apple Tea
Arm Type
Placebo Comparator
Arm Description
Subjects will drink 1000ml/day of apple tea for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Yerba Mate Tea
Intervention Description
Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Green tea
Intervention Description
Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
Intervention Type
Dietary Supplement
Intervention Name(s)
Apple tea
Intervention Description
Before and after 8 weeks, serum lipids, C-reactive protein and fibrinogen will be measured. They will also be tested for glycemia, insulin, aminotransferases, bilirubin. Anthropometric measurements will be also performed at week 0 and 8. The subjects will receive instructions to maintain their usual dietary intake and normal physical activity.
Primary Outcome Measure Information:
Title
Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Decreases in body weight, body mass index, body fat ratio, abdominal and waist circumferences and waist to hip ratio. Changes in glucose and insulin will also be evaluated.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 35-60 years
non-treated dyslipidemia (TC > 200mg/dL and/or TG > 150 mg/dL and/or HDL-c < 40 mg/dL for men and 50mg /dL for women)
BMI 25-35 Kg/m²
Exclusion Criteria:
use or indication for use of lipid-lowering agents and/or vitamin supplement
non-steroids anti inflammatory use
hormone replacement therapy
contraceptive use
pregnancy
nursing
unexplained weight loss (>2 Kg) 2 months before the study
altered hepatic function
those who do not sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Lúcia Portal, PhD
Organizational Affiliation
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruna Pontin, MD
Organizational Affiliation
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lúcia Campos Pellanda, PhD
Organizational Affiliation
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Cardiologia / Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90620-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruna Pontin, MD
Phone
55 54 9129 1027
Email
brunapontin@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
30660196
Citation
Balsan G, Pellanda LC, Sausen G, Galarraga T, Zaffari D, Pontin B, Portal VL. Effect of yerba mate and green tea on paraoxonase and leptin levels in patients affected by overweight or obesity and dyslipidemia: a randomized clinical trial. Nutr J. 2019 Jan 19;18(1):5. doi: 10.1186/s12937-018-0426-y.
Results Reference
derived
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Cardioprotective Effects of Green Tea Versus Maté Intake
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