Cardioprotective Effects of Green Tea Versus Maté Intake
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00933647
First received: July 6, 2009
Last updated: July 10, 2009
Last verified: July 2009
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Purpose
The investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia Inflammation Obesity |
Dietary Supplement: Yerba Mate Tea Dietary Supplement: Green tea Dietary Supplement: Apple tea |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Yerba Mate and Green Tea Consumption on Cardiovascular Risk Factors in Dyslipidemic and Overweight Subjects |
Resource links provided by NLM:
Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:
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). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 195 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Yerba Mate Tea
Subjects will drink 1000ml/day of yerba mate tea for 8 weeks.
|
Dietary Supplement: Yerba Mate Tea
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.
|
|
Active Comparator: Green Tea
Subjects will drink 1000ml/day of green tea for 8 weeks.
|
Dietary Supplement: Green tea
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.
|
|
Placebo Comparator: Apple Tea
Subjects will drink 1000ml/day of apple tea for 8 weeks.
|
Dietary Supplement: Apple tea
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.
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933647
Locations
| Brazil | |
| Instituto de Cardiologia / Fundação Universitária de Cardiologia | Recruiting |
| Porto Alegre, RS, Brazil, 90620-001 | |
| Contact: Bruna Pontin, MD 55 54 9129 1027 brunapontin@hotmail.com | |
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
| Study Director: | Vera Lúcia Portal, PhD | Instituto de Cardiologia / Fundação Universitária de Cardiologia |
| Principal Investigator: | Bruna Pontin, MD | Instituto de Cardiologia / Fundação Universitária de Cardiologia |
| Study Director: | Lúcia Campos Pellanda, PhD | Instituto de Cardiologia / Fundação Universitária de Cardiologia |
More Information
No publications provided
| Responsible Party: | Bruna Pontin, Instituto de Cardiologia / Fundação Universitária de Cardiologia |
| ClinicalTrials.gov Identifier: | NCT00933647 History of Changes |
| Other Study ID Numbers: | Projeto Chimarrão |
| Study First Received: | July 6, 2009 |
| Last Updated: | July 10, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
|
Camellia sinensis Ilex paraguariensis Green tea Yerba mate tea |
Maté Dyslipidemia Inflammation Obesity |
Additional relevant MeSH terms:
|
Inflammation Obesity Dyslipidemias Pathologic Processes Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013