Clinical trial NCT00933647: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemia
Inflammation
Obesity
Keywords: Camellia sinensis
Ilex paraguariensis
Green tea
Yerba mate tea
Maté
Dyslipidemia
Inflammation
Obesity
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 195
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen).
timeFrame: 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia / Fundação Universitária de Cardiologia
state: RS
Study officials:
affiliation: Instituto de Cardiologia / Fundação Universitária de Cardiologia
name: Vera Lúcia Portal, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Cardiologia / Fundação Universitária de Cardiologia
name: Bruna Pontin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Cardiologia / Fundação Universitária de Cardiologia
name: Lúcia Campos Pellanda, PhD
role: STUDY_DIRECTOR
References:
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.