NCT07000825

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universidade Federal da Fronteira Sul · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome
• Diabetes
• Oxidative Stress
• Dyslipidemia
• Inflamation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Intervention 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.

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2025-06-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: Brazil