Cardioprotective Effects of Green Tea Versus Maté Intake

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Yerba Mate and Green Tea Consumption on Cardiovascular Risk Factors in Dyslipidemic and Overweight Subjects

Conditions
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Dyslipidemia, Inflammation, Obesity

Intervention / Treatment
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* Dietary Supplement: Yerba Mate Tea
* Dietary Supplement: Green tea
* Dietary Supplement: Apple tea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yerba Mate Tea<br>Subjects will drink 1000ml/day of yerba mate tea for 8 weeks. | Dietary Supplement: Yerba Mate Tea<br>* 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.<br>|
| Active Comparator: Green Tea<br>Subjects will drink 1000ml/day of green tea for 8 weeks. | Dietary Supplement: Green tea<br>* 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.<br>|
| Placebo Comparator: Apple Tea<br>Subjects will drink 1000ml/day of apple tea for 8 weeks. | Dietary Supplement: Apple tea<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen). |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Camellia sinensis, Ilex paraguariensis, Green tea, Yerba mate tea, Maté, Dyslipidemia, Inflammation, Obesity