protocolSection identificationModule nctId: NCT06289439, orgStudyIdInfo id: 2024.05.25, briefTitle: Effect of Green Tea Supplementation in Older Adult Women, acronym: GTAW, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Valladolid, class: OTHER, collaborators name: Sanidad de Castilla y León, collaborators name: Instituto de Neurociencia de Castillas y Leon, descriptionModule briefSummary: Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2)., conditionsModule conditions: Female, conditions: Older Adults, conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group placebo-controlled randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Green tea (Camellia sinensis) 1000 mg as extract, interventions name: Placebo, outcomesModule primaryOutcomes measure: Creatine kinase (CK), primaryOutcomes measure: Lactate dehydrogenase (LDH), secondaryOutcomes measure: Myoglobin (Mb), secondaryOutcomes measure: Alanine Aminotransferase (ALT), secondaryOutcomes measure: Aspartate Aminotransferase (AST), secondaryOutcomes measure: Interleukin 6 (IL-6), secondaryOutcomes measure: C-reactive protein (PCR), secondaryOutcomes measure: Testosterone, secondaryOutcomes measure: Cortisol, secondaryOutcomes measure: Miostatin (GDF8), secondaryOutcomes measure: advanced oxidation protein products (AOPP), secondaryOutcomes measure: lipid peroxidation (LPO), secondaryOutcomes measure: Oxygen radical absorption (ORAC), secondaryOutcomes measure: Total antioxidant status (TAS), secondaryOutcomes measure: Total antioxidant capacity (TAC), secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF), eligibilityModule sex: FEMALE, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences, University of Valladolid Soria Campus, status: RECRUITING, city: Soria, zip: 42004, country: Spain, contacts name: Diego Fernández Lázaro, Vice Dean, role: CONTACT, phone: +34658073375, email: diego.fernandez.lazaro@uva.es, geoPoint lat: 41.76401, lon: -2.46883, hasResults: False