Diabetes, Dyslipidemia, Inflamation, Metabolic Syndrome, Oxidative Stress
Conditions
Keywords
glycemic control, lipid metabolism, oxidative stress, metabolic syndrome, adipose tissue
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 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.
Interventions
DIETARY_SUPPLEMENTIntervention with yerba mate extract or placebo
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.
Sponsors
Universidade Federal da Fronteira Sul
Itaipu Technological Park (ITP)
Fundação Araucária
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a randomized, double-blind, parallel-group clinical trial with a 90-day intervention. The trial will be registered with the Brazilian Clinical Trial Registry - Ministry of Health (https://ensaiosclinicos.gov.br/) and will be conducted in accordance with the CONSORT guidelines (Schulz KF, Altman DG, Moher D, for CONSORT Group. CONSORT Statement 2010: updated guidelines for reporting parallel-group randomized trials). The clinical trial will be conducted from March 2025 to July 2026.
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. men and women; 2. aged between 40 and 65 years; 3. with no previous cardiovascular history; 4. individuals who are non-smokers or who have stopped smoking in the last 3 years; 5. individuals who agree to maintain a habitual diet and physical activity; 6. 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; 7. individuals who are not taking hypoglycemic, antihypertensive or anticholesterolemic drugs and; 8. individuals who are overweight or obese (BMI≥25 to 34 Kg/m2 ); 9. 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
1. diagnosis uncontrolled metabolic or endocrine pathologies; 2. who have undergone obesity surgery; 3. post-menopausal women; 4. pregnant and breastfeeding women; 5. use of antipsychotics; 6. with a vegetarian or vegan diet; 7. who use probiotics and food supplements with antioxidant characteristics; 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body mass index | 12 weeks | measured by weight in kilograms and height in meters |
| fat percentage | 12 weeks | measured by electrical bioimpedance |
| diabetes | 12 weeks | measured by plasma glucose, fructosamine and C peptide |
| abdominal fat | 12 weeks | measured by waist circumference |
| dyslipidemia | 12 weeks | measured by lipid profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflamation | 12 weeks | measured by cytokine levels and C reative-protein |
| oxidative stress | 12 weeks | measured by lipid peroxidation |
| transcriptome | 12 weeks | measured by gene expression |
| gut microbiota | 12 weeks | measured by microbiome DNA |
| Iron metabolism | 12 weeks | measured by ferritin, seric iron, transferrin, iron-binding capacity, and hepcidin |
| metabolism | 12 weeks | Mensured by hepatic enzymes, uric acid, creatinin and bilirubin |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATOREloá A Koehnlein, Doctorate
Universidade Federal da Fronteira Sul
Outcome results
None listed