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NCT Number: NCT07000825

EFFECTS OF A YERBA MATE EXTRACT IN REDUCING METABOLIC SYNDROME IN OVERWEIGHT INDIVIDUALS

Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating metabolic pathways in pre-clinical models. However, its beneficial effets in clinical trials have yet to be elucidated. Overweight and chronic non-communicable diases are urgent public health conditions and reducing the risk of these conditions through food sources is one of the most sustainable approaches. This study aims to evaluate the impact of a standardized extract of yerba mate on nutritional, biochemical, metabolic, inflammatory and antioxidant status parameters in overweight individuals compared to a placebo. A double-blind, parallel, randomized, placebo- controlled clinical trial will be conducted involving 80 overweight individuals. The subjects will receive an encapsulated yerba mate extract totaling 2,250 mg or a corresponding placebo, fractionated three times a day. This amount was defined according to previous studies thet estimated the habitual intake of yerba mate in the form of chimarrão or tererê by adults in a city in the southern region of the country. Anthropometric measurements, composition, blood pressure and blod and stool samples will be collected for nutritional assessment, metabolic and inflammatory parameters and antioxidant status assessment on days 0 and 90. The data will be analyzed descriptively and inferentially. Differences in the individuals characteristics at baseline and comparisons between groups will be aseessed using the difference of means test (depending on the normality of the data) and chi-square or Fisher-s exact test for categorical variabes, In addition, to compare the effect of the intervention between the groups, a two-way analysis of covariance will be used. A 5% significance level will be adopted. It is expect to find positive effects of yerba mate extract on the parameters assessed.

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Key information

Conditions

Metabolic Syndrome Diabetes Diabetes Mellitus Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflamation Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal da Fronteira Sul

Realeza, Paraná, 85770-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men and women;
  • aged between 40 and 65 years;
  • with no previous cardiovascular history;
  • individuals who are non-smokers or who have stopped smoking in the last 3 years;
  • individuals who agree to maintain a habitual diet and physical activity;
  • individuals who agree to maintain habitual consumption of polyphenol-rich beverages (yerba mate, teas, coffee, wine, cocoa, soy milk and fruit juice) during the course of the study;
  • individuals who are not taking hypoglycemic, antihypertensive or anticholesterolemic drugs and;
  • individuals who are overweight or obese (BMI≥25 to 34 Kg/m2 );
  • individuals who have given up nutritional monitoring at least 3 months or who are undergoing nutritional treatment, but who are not showing weight changes of >5% in the last 3 months.

Exclusion criteria

  • diagnosis uncontrolled metabolic or endocrine pathologies;
  • who have undergone obesity surgery;
  • post-menopausal women;
  • pregnant and breastfeeding women;
  • use of antipsychotics;
  • with a vegetarian or vegan diet;
  • who use probiotics and food supplements with antioxidant characteristics;
  • those who have had a weight change of more than 10% in the last 3 months; 9) in treatment for excess body weight (hypocaloric diet or current nutritional treatment);
  • smokers or chronic alcoholics; 11) Severe hypertension, history of cardiovascular disease with clinical complications such as: acute myocardial infarction and other coronary heart disease; 12) individuals with known malignant neoplasms, gastrointestinal diseases, kidney disease and/or liver disease.

Treatment and study plan

Intervention with yerba mate extract or placebo

Dietary Supplement

The standardized extract of yerba mate (Ilex paraguariensis) will be supplied by Sustentec. It is a dry extract of the plant's green, powdered leaves, obtained through aqueous extraction. The extract was obtained by infusing the dried leaves of the plant and the drying process was carried out using a spray-dryer (ratio 6/1 leaves/extract). The extract will be encapsulated containing 250 mg each. Administration Intervention group: 2,250 mg of standardized yerba mate extract will be administered in 9 capsules, 3 times a day, just before the main meals. This amount will provide approximately 980 mg of caffeoylquinic acids/day, which was defined based on the estimated usual intake of caffeoylquinic acids by individuals in a municipality in the southern region of the country, from traditional drinks made with yerba mate (chimarrão and tereré) (Gebara et al., 2017). Placebo group: 9 capsules containing maltodextrin will be administered 3 times a day, just before the main meals.

Primary outcomes

  1. body mass index

    Time frame: 12 weeks

    measured by weight in kilograms and height in meters

  2. fat percentage

    Time frame: 12 weeks

    measured by electrical bioimpedance

  3. diabetes

    Time frame: 12 weeks

    measured by plasma glucose, fructosamine and C peptide

  4. abdominal fat

    Time frame: 12 weeks

    measured by waist circumference

  5. dyslipidemia

    Time frame: 12 weeks

    measured by lipid profile

  6. diabetes

    Time frame: 12 weeks

    measured by insulin levels

Secondary outcomes

  1. inflamation

    Time frame: 12 weeks

    measured by cytokine levels and C reative-protein

  2. oxidative stress

    Time frame: 12 weeks

    measured by lipid peroxidation

  3. oxidative stress

    Time frame: 12 weeks

    measured by plasma thio levels

  4. oxidative stress

    Time frame: 12 weeks

    measured by total antioxidant capacity of plasma

  5. transcriptome

    Time frame: 12 weeks

    measured by gene expression

  6. gut microbiota

    Time frame: 12 weeks

    measured by microbiome DNA

  7. Iron metabolism

    Time frame: 12 weeks

    measured by ferritin, seric iron, transferrin, iron-binding capacity, and hepcidin

  8. metabolism

    Time frame: 12 weeks

    Mensured by hepatic enzymes, uric acid, creatinin and bilirubin

Sponsors and collaborators

Lead sponsor

Universidade Federal da Fronteira Sul

Other

Collaborators

  • Fundação Araucária
  • Itaipu Technological Park (ITP)

Registry information

Official study title

EFFECTS OF INGESTING AN EXTRACT OR YERBA MATE (ILEX PARAGUARIENSIS) ON NUTRICIONAL, METABOLIC AND INFLAMMATORY PARAMETERS AND OXIDATIVE STATUS IN OVERWEIGHT INDIVIDUALS

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jun 3, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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