Clinical trial NCT06729905: Study of the Effects of Yerba Mate on Cardiometabolic Health
Official title: Study of the Effects of Yerba Mate on Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Hypercholerolemia
Keywords: Yerba mate
Cardiovascular health
Inflammation
Blood lipids
Glucose homeostasis
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2024-12-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. The main questions it aims to answer are:

Does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? May healthy persons also benefit from the consumption of yerba mate tea?

Researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons.

Participants will:

Drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months.

Visit the clinic at the beginning and end of each 2-month period for checkups and tests Refraing from consuming coffee and some foods during the study. Complete a dietary questionnaire during 3 days before each visit to the clinic.

Detailed description: This is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health.

After a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. After a 3-week wash-out, they will change to consume during 8 weeks the other drink.

A nurse will collect a fasting blood sample at the beginning and end of each intervention stage. Blood pressure and anthropometric parameters will be measured. A 72-h dietary record will be completed by participants before each visit to the Human Nutrition Unit (HNU) at the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC).

During the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. Other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted.

Blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.

Eligibility criteria: Inclusion Criteria:

* Body mass index between 20-25 kg/m2
* Total cholesterol \< 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or
* LDL cholesterol \< 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.

Exclusion Criteria:

* Smoking
* Pregnant/lactating women
* Vegetarians/vegans
* Consumption of vitamins or dietary supplements
* Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia
* On prescription drugs (statins) or on antibiotics 6 months before the study

Primary outcomes:
measure: Blood lipids
timeFrame: From enrollment to the end of each treatment at 8 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Inflammatory cytokines
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Fasting blood glucose
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Fasting blood insulin
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Insulin resistance
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Insulin sensitivity
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Hormones, incretins and adipokines levels
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Cytokines, chemokines and cell-adherence molecules levels
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Liver function
timeFrame: From enrollment to the end of each treatment at 8 weeks
measure: Anthropometry
timeFrame: From enrollment to the end of each treatment at 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study officials:
affiliation: ICTAN-CSIC
name: Laura Bravo, Professor
role: PRINCIPAL_INVESTIGATOR
References: