Clinical trial NCT06896175: Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile
Official title: Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile of Consumes in the Department of Caaguazu, Paraguay
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lipid Metabolism Disorders
Lead sponsor: Universidad Nacional de Caaguazu
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Itaugua, MSPyBS, Paraguay)
name: Instituto Nacional de Salud, Paraguay
name: Universidad de La Frontera
name: McMaster University
name: Universidad del Cauca
First posted: 2025-03-26
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First, they will be divided into two groups: YMA (Yerba harvested at the beginning of the safra) and YMB (Yerba harvested at the end of the safra). Both groups are then divided into three strata: consumption of mate only, consumption of terere only, consumption of both mate and terere.
Primary purpose: PREVENTION

Brief summary: Introduction: This project studies the impact of Ilex paraguariensis harvest time, commonly known as yerba mate, and its consumption mode (mate, tereré, and mate/terere) on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Yerba mate is rich in bioactive compounds such as polyphenols, xanthines, and saponins. There are no clinical trials conducted in Paraguay with our Ilex paraguariensis plantations that have analyzed the influence of harvest time on the yerba mate production process and the infusion mode, in relation to its effect on dyslipidemias. General Objective: To establish the effectiveness of Ilex paraguariensis harvest time and the mode of consumption of the produced yerba mate on the lipid profile of consumers in the Department of Caaguazú, Paraguay. Methodology: The research approach will be quantitative, using a triple-blind randomized clinical trial design. Participants will be regular consumers of yerba mate, divided into groups based on harvest time (beginning or end of the harvest) and consumption mode (mate, tereré, or both). Lipid profile measurements will be taken at baseline and at 30, 90, and 180 days after consumption. Yerba mate samples will be analyzed and classified according to their bioactive properties before being blinded to the researchers and participants. Expected results: a report on the social, cultural, and anthropometric characterization of regular consumers of mate and tereré, and a report on the concentrations of the bioactive properties of yerba mate; polyphenols, xanthines, saponins from Ilex paraguariensis harvested at the beginning and end of the harvest and the database of patients with baseline lipid profile results, at 30, 90, and 180 days of mate and tereré consumers with yerba mate prepared randomly according to the harvest time of the Ip (beginning or end of harvest) analyzed.


Eligibility criteria: Inclusion Criteria:

1. Individuals of both sexes, between 18 and 60 years of age, residing in the country, who consume prepared yerba mate.
2. Consumers of mate or tereré and mate/terere who agree to consume the yerba mate samples provided by the research team, which will be masked from laboratory analysis.
3. Two weeks of abstinence from consuming prepared yerba mate, either as mate or tereré, prior to randomization for the trial.
4. Consume exclusively prepared yerba mate in the prescribed manner (quantity of yerba, frequency of consumption, and sips), either in its mate or tereré form independently, and for those who consume both forms daily.
5. Do not change the yerba mate consumer's usual diet or regular physical activity during the trial period.
6. Agree to know the laboratory results of the lipid profile only at the end of the trial (180 days after the start).

Exclusion Criteria:

1. Individuals receiving lipid-lowering treatment at the start of the trial.
2. Consuming any other type of yerba mate not provided by the principal investigator.
3. Individuals requiring vitamins as a nutritional supplement.
4. Individuals taking thermogenic supplements.
5. Individuals consuming cooked mate.
6. Addiction to medicinal plants or herbs, both mate and tereré.
7. Individuals with a personal history of coronary artery disease.

Primary outcomes:
measure: Effect on lipid profile
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
name: Guiomar Viveros
role: STUDY_CHAIR
affiliation: Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
name: Gloria Gonzalez
role: STUDY_DIRECTOR
affiliation: Universidad Nacional de Caaguazu, Facultad de Ciencias de la Salud
name: Angel Rolon
role: PRINCIPAL_INVESTIGATOR
References: