DyslipidemiaPhase 3NCT00933647
Cardioprotective Effects of Green Tea Versus Maté Intake
A Phase 3 study testing Yerba Mate Tea, Green tea and Apple tea in people with Dyslipidemia and Inflammation, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
The investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Inflammation, Obesity
- What is being tested?
- Yerba Mate Tea, Green tea and Apple tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- unexplained weight loss (>2 Kg) 2 months before the study
- altered hepatic function
- those who do not sign the informed consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620-001
Bruna Pontin, MD, 55 54 9129 1027, brunapontin@hotmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Yerba Mate Tea, Green tea, Apple tea
- Keywords
- Camellia sinensis, Ilex paraguariensis, Green tea, Yerba mate tea, Maté, Dyslipidemia, Inflammation, Obesity
- Medical subject headings
- Dyslipidemias, Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yerba Mate TeaDietary 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 teaDietary 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 teaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Yerba Mate Tea | Experimental | Subjects will drink 1000ml/day of yerba mate tea for 8 weeks. Receives: Dietary Supplement: Yerba Mate Tea |
| Green Tea | Active comparator | Subjects will drink 1000ml/day of green tea for 8 weeks. Receives: Dietary Supplement: Green tea |
| Apple Tea | Placebo comparator | Subjects will drink 1000ml/day of apple tea for 8 weeks. Receives: Dietary Supplement: Apple tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen).
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startNov 2007
- Primary completionSep 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Investigators
- Vera Lúcia Portal, PhD, Study director, Instituto de Cardiologia / Fundação Universitária de CardiologiaBruna Pontin, MD, Principal investigator, Instituto de Cardiologia / Fundação Universitária de CardiologiaLúcia Campos Pellanda, PhD, Study director, Instituto de Cardiologia / Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933647
- Sponsor's protocol ID
- Projeto Chimarrão
- Status last verified
- Jul 2009
- First submitted
- 6 Jul 2009
- Last updated
- 13 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30660196
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yerba Mate and Green Tea Consumption on Cardiovascular Risk Factors in Dyslipidemic and Overweight Subjects
- ClinicalTrials.gov ID
- NCT00933647
- Acronym / sponsor ID
- Projeto Chimarrão
- Conditions
- Dyslipidemia, Inflammation, Obesity
- Keywords
- Camellia sinensis, Ilex paraguariensis, Green tea, Yerba mate tea, Maté, Dyslipidemia, Inflammation, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yerba Mate Tea | Experimental | Dietary Supplement: Yerba Mate TeaSubjects will drink 1000ml/day of yerba mate tea for 8 weeks. |
| Green Tea | Active comparator | Dietary Supplement: Green teaSubjects will drink 1000ml/day of green tea for 8 weeks. |
| Apple Tea | Placebo comparator | Dietary Supplement: Apple teaSubjects will drink 1000ml/day of apple tea for 8 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- use or indication for use of lipid-lowering agents and/or vitamin supplement
- non-steroids anti inflammatory use
- hormone replacement therapy
- contraceptive use
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yerba Mate TeaBefore 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 | Yerba Mate Tea |
| Green teaBefore 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 |
| Apple teaBefore 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 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2009.
- Derived from this study: PubMed 30660196Balsan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Porto Alegre, Brazil
Vera Lúcia Portal, PhD study director
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Bruna Pontin, MD principal investigator
Instituto de Cardiologia / Fundação Universitária de Cardiologia
Lúcia Campos Pellanda, PhD study director
Instituto de Cardiologia / Fundação Universitária de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Yerba Mate Tea, Green tea and Apple tea in people with Dyslipidemia and Inflammation, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2009.