Noncommunicable Diseases Overweight
Conditions
Interventions
A double-blind, parallel, randomized, placebo-controlled clinical trial will be conducted involving 80 overweight individuals. Participants will receive either an encapsulated yerba mate extract total
Sponsors
Universidade Federal da Fronteira Sul
Universidade Federal da Fronteira Sul
Eligibility
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women; age range between 40 and 65 years; without a history of cardiovascular disease; non-smokers or individuals who quit smoking in the past 3 years; individuals willing to maintain their usual diet and physical activity; individuals willing to maintain their habitual consumption of beverages rich in polyphenols (yerba mate, teas, coffee, wine, cocoa, soy milk, and fruit juices) during the study; individuals not using hypoglycemic, antihypertensive, or cholesterol-lowering medications; individuals who are overweight or obese (BMI = 25 to 34 kg/m²); individuals who discontinued nutritional counseling at least 3 months ago or who are undergoing nutritional treatment but have not experienced weight changes >5% in the last 3 months.
Exclusion criteria
Exclusion criteria: Diagnosis of uncontrolled metabolic or endocrine disorders; individuals who have undergone obesity surgery; postmenopausal women; pregnant and breastfeeding women; use of antipsychotics; those following vegetarian or vegan diets; individuals using probiotics or dietary supplements with antioxidant properties; those with weight fluctuations greater than 10% in the past three months; undergoing treatment for excess body weight (current low-calorie diet or nutritional treatment); smokers or chronic alcohol users; severe arterial hypertension, history of cardiovascular disease with clinical complications such as acute myocardial infarction and other coronary diseases; individuals with known malignant neoplasms, gastrointestinal diseases, kidney disease, and/or liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that anthropometric indicators of adiposity will be reduced over a 90-day period, verified through the assessment of body composition and waist circumference, based on a variation of at least 5% in pre- and post-intervention measurements.;An improvement in glucose metabolism is expected within 90 days, verified through the evaluation of glycemic, insulinemic, glycated hemoglobin, and fructosamine responses, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in lipid metabolism is expected within 90 days, verified through lipid profile assessment, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in inflammatory markers is expected within 90 days, verified through the evaluation of cytokines and hormones, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in blood pressure is expected within 90 days, verified by assessing blood pressure levels, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in adiposity-related hormones is expected within 90 days, verified through adiponectin and GLP-1 assessment, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in oxidative status is expected within 90 days, verified through the evaluation of antioxidants and reactive species, based on a variation of at least 10% in pre- and post-intervention measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in gene expression related to metabolism is expected within 90 days, verified through genomic and gut microbiota assessment, based on a variation of at least 10% in pre- and post-intervention measurements.;An improvement in uric acid and iron metabolism is expected within 90 days, verified by evaluating serum levels of uric acid, serum iron, ferritin, transferrin, transferrin saturation and binding capacity, and hepcidin, based on a variation of at least 10% in pre- and post-intervention measurements. | — |
Countries
BR
Contacts
Public ContactEloá Koehnlein
Universidade Federal da Fronteira Sul
Outcome results
None listed