Cardioprotective Effects of Green Tea Versus Maté Intake

July 10, 2009 updated by: Instituto de Cardiologia do Rio Grande do Sul

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90620-001
        • Recruiting
        • Instituto de Cardiologia / Fundação Universitária de Cardiologia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (ESTIMATE)

July 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2009

Last Update Submitted That Met QC Criteria

July 10, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Projeto Chimarrão

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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