Status:
NOT_YET_RECRUITING
EFFECTS OF A YERBA MATE EXTRACT IN REDUCING METABOLIC SYNDROME IN OVERWEIGHT INDIVIDUALS
Lead Sponsor:
Universidade Federal da Fronteira Sul
Collaborating Sponsors:
Itaipu Technological Park (ITP)
Fundação Araucária
Conditions:
Metabolic Syndrome
Diabetes
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
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 pote...
Eligibility Criteria
Inclusion
- 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
- 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);
- 10\) 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.
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07000825
Start Date
June 10 2025
End Date
December 1 2029
Last Update
June 3 2025
Active Locations (1)
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1
Universidade Federal da Fronteira Sul
Realeza, Paraná, Brazil, 85770-000