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
Sponsor:
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

July 6, 2009
July 10, 2009
November 2007
September 2009   (final data collection date for primary outcome 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). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides) and inflammatory profile (C- reactive protein and fibrinogen). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00933647 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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Cardioprotective Effects of Green Tea Versus Maté Intake
Effects of Yerba Mate and Green Tea Consumption on Cardiovascular Risk Factors in Dyslipidemic and Overweight Subjects

The investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dyslipidemia
  • Inflammation
  • Obesity
  • 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.
  • 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.
  • 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.
  • Experimental: Yerba Mate Tea
    Subjects will drink 1000ml/day of yerba mate tea for 8 weeks.
    Intervention: Dietary Supplement: Yerba Mate Tea
  • Active Comparator: Green Tea
    Subjects will drink 1000ml/day of green tea for 8 weeks.
    Intervention: Dietary Supplement: Green tea
  • Placebo Comparator: Apple Tea
    Subjects will drink 1000ml/day of apple tea for 8 weeks.
    Intervention: Dietary Supplement: Apple tea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
195
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 60 Years
Yes
Brazil
 
NCT00933647
Projeto Chimarrão
Yes
Bruna Pontin, Instituto de Cardiologia / Fundação Universitária de Cardiologia
Instituto de Cardiologia do Rio Grande do Sul
Not Provided
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
Instituto de Cardiologia do Rio Grande do Sul
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP