NCT00933647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

1.8 years

First QC Date

July 6, 2009

Last Update Submit

July 10, 2009

Conditions

DyslipidemiaInflammationObesity

Keywords

Camellia sinensisIlex paraguariensisGreen teaYerba mate teaMatéDyslipidemiaInflammationObesity

Outcome Measures

Primary Outcomes (1)

  • Improvement of lipid (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol / HDL-cholesterol ratio) and inflammatory profiles (C- reactive protein and fibrinogen).

    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.

    8 weeks

Study Arms (3)

Yerba Mate Tea

EXPERIMENTAL

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

Dietary Supplement: Yerba Mate Tea

Green Tea

ACTIVE COMPARATOR

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

Dietary Supplement: Green tea

Apple Tea

PLACEBO COMPARATOR

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

Dietary Supplement: Apple tea

Interventions

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.

Yerba Mate Tea
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.

Green Tea
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.

Apple Tea

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia / Fundação Universitária de Cardiologia

Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30660196DERIVED

MeSH Terms

Conditions

DyslipidemiasInflammationObesity

Interventions

Tea

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vera Lúcia Portal, PhD

    Instituto de Cardiologia / Fundação Universitária de Cardiologia

    STUDY DIRECTOR

  • Bruna Pontin, MD

    Instituto de Cardiologia / Fundação Universitária de Cardiologia

    PRINCIPAL INVESTIGATOR

  • Lúcia Campos Pellanda, PhD

    Instituto de Cardiologia / Fundação Universitária de Cardiologia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 7, 2009

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

BR(1)