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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Obesity
Inflammation
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014