Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-31 @ 2:09 PM
Study NCT ID:
NCT06729905
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2024-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effects of Yerba Mate on Cardiometabolic Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2015-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2024-12-07', 'studyFirstSubmitQcDate': '2024-12-07', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood lipids', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change in blood levels of total cholesterol or LDL-cholesterol or VLDL-cholesterol or HDL-cholesterol or triglycerides or phospholipids at the end of the intervention with yerba mate'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Changes in blood pressure at the end of the intervention with yerba mate.'}, {'measure': 'Inflammatory cytokines', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change in the levels of C-reactive protein (CRP), or pro-inflammatory cytokines (tumor necrosis factor-alpha (TNF-a), or interferon gamma (IFN-g), interleukin (IL)-1beta (IL-1b), or IL-2, or IL-5, or IL-6, or IL-7, or IL-8, or IL-12 or IL-13)) or anti-inflammatory cytokines IL-4 or IL-10 at the end of the intervention with yerba mate'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change of fasting blood glucose levels at the end of the intervention with yerba mate'}, {'measure': 'Fasting blood insulin', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change of fasting insulin levels at the end of intervention with yerba mate'}, {'measure': 'Insulin resistance', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) at the end of intervention with yerba mate'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Change in quantitative insulin levels sensitivity check index (QUICKI) at the end of the intervention with yerba mate. Higher score in QUICKI means a better outcome compared to initial values.'}, {'measure': 'Hormones, incretins and adipokines levels', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Changes in serum levels of C peptide or glucagon or glucagon inhibitory peptide (GIP) or glucagon-like peptide type 1 (GLP-1) or ghrelin or leptin or resistin or plasminogen activator inhibitor type 1 (PAI-1) or visfatin at the end of the intervention with yerba mate.'}, {'measure': 'Cytokines, chemokines and cell-adherence molecules levels', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Changes in serum levels of granulocyte (G-CSF) or granulocyte/macrophague (GM-CSF) colony-stimulating factors, or monocyte-chemoattractant protein-1 (MCP-1) or macrophage inflammatory protein-1beta (MIP-1b) or vascular (VCAM-1) or intracellular (ICAM-1) adhesion molecules at the end of the intervention with yerba mate.'}, {'measure': 'Liver function', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'No changes in serum levels of alanin transferase (ALAT), or aspartate transferase (ASAT) at the end of the intervention with yerba mate.'}, {'measure': 'Anthropometry', 'timeFrame': 'From enrollment to the end of each treatment at 8 weeks', 'description': 'Changes in body weight or body fat percentage or body circunferences (wais, or hip, or thigh, or brachial) or skinfolds (tricipital or subscapular) at the end of the intervention with yerba mate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yerba mate', 'Cardiovascular health', 'Inflammation', 'Blood lipids', 'Glucose homeostasis'], 'conditions': ['Cardiovascular Risk', 'Hypercholerolemia']}, 'referencesModule': {'references': [{'pmid': '40263915', 'type': 'DERIVED', 'citation': 'Bravo L, Martinez-Lopez S, Sierra-Cinos JL, Mateos R, Sarria B. Yerba Mate (Ilex paraguariensis St. Hill.) Tea May Have Cardiometabolic Beneficial Effects in Healthy and At-Risk Subjects: A Randomized, Controlled, Blind, Crossover Trial in Nonhabitual Consumers. Mol Nutr Food Res. 2025 Aug;69(15):e70065. doi: 10.1002/mnfr.70065. Epub 2025 Apr 22.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nResearchers 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.\n\nParticipants will:\n\nDrink 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.\n\nVisit 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.', 'detailedDescription': '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.\n\nAfter 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.\n\nA 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).\n\nDuring 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.\n\nBlood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 20-25 kg/m2\n* Total cholesterol \\< 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or\n* LDL cholesterol \\< 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.\n\nExclusion Criteria:\n\n* Smoking\n* Pregnant/lactating women\n* Vegetarians/vegans\n* Consumption of vitamins or dietary supplements\n* Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia\n* On prescription drugs (statins) or on antibiotics 6 months before the study'}, 'identificationModule': {'nctId': 'NCT06729905', 'acronym': 'INFU-SALUD', 'briefTitle': 'Study of the Effects of Yerba Mate on Cardiometabolic Health', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición'}, 'officialTitle': 'Study of the Effects of Yerba Mate on Cardiometabolic Health', 'orgStudyIdInfo': {'id': 'AGL2010-18269'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yerba mate', 'description': 'Consumption of three cups of a yerba mate tea per day', 'interventionNames': ['Dietary Supplement: Yerba mate tea']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Consuming water or an isotonic drink, free of polyphenols or caffeine.', 'interventionNames': ['Dietary Supplement: Control drink']}], 'interventions': [{'name': 'Yerba mate tea', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumption of three cups per day of a beverage prepared with yerba mate', 'armGroupLabels': ['Yerba mate']}, {'name': 'Control drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumption of water or an isotonic drink, free of polyphenols or caffeine. Abstention of consuming coffee.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Laura Bravo, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICTAN-CSIC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Ciencia y Tecnología de Alimentos y Nutrición', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Science and Innovation, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}