Cardioprotective Effects of Green Tea Versus Maté Intake

NCT ID: NCT00933647

Last Updated: 2009-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Dyslipidemia; Inflammation; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yerba Mate Tea

Subjects will drink 1000ml/day of yerba mate tea for 8 weeks.

Group Type: EXPERIMENTAL

Yerba Mate Tea

Intervention Type: DIETARY_SUPPLEMENT

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.

Green Tea

Subjects will drink 1000ml/day of green tea for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Green tea

Intervention Type: DIETARY_SUPPLEMENT

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.

Apple Tea

Subjects will drink 1000ml/day of apple tea for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Apple tea

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Principal Investigators

Vera Lúcia Portal, PhD

Role: STUDY_DIRECTOR

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Bruna Pontin, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Lúcia Campos Pellanda, PhD

Role: STUDY_DIRECTOR

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Locations

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Bruna Pontin, MD

Role: primary

brunapontin@hotmail.com

55 54 9129 1027

References

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.

Reference Type: DERIVED

PMID: 30660196 (View on PubMed)

Other Identifiers

Projeto Chimarrão

Identifier Type: -

Identifier Source: org_study_id