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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06289439
Other study ID # 2024.05.25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 5, 2024
Est. completion date April 1, 2025

Study information

Verified date March 2024
Source University of Valladolid
Contact Diego Fernández Lázaro, Professor; PhD
Phone +34658073375
Email diego.fernandez.lazaro@uva.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 1, 2025
Est. primary completion date December 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria: - Older adult women between 60 and 80 years old, with the ability to carry out a physical activity program adapted to their age and health condition. Exclusion Criteria: 1. Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value). 2. Acute/chronic heart failure with NYHA (New York Heart Association) scale >II. 3. Uncontrolled hypertension (>180/100 mm Hg). 4. Uncontrolled orthostatic hypotension. 5. Uncontrolled atrial or ventricular arrhythmias, aortic dissecting aneurysm, severe aortic stenosis, acute endocarditis/pericarditis. 6. Recent acute myocardial infarction (3 to 6 months) or unstable angina. 7. Acute thromboembolic disease. 8. Acute/chronic respiratory failure. 9. Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D. 10. Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia. 11. Recent bone fracture (last month). 12. History of dementia (suspected by the MAP environment and diagnosed). 13. Previous supplementation with amino acids or other nutritional compounds to improve physical performance. 14. Any other circumstance that your doctor considers prevents physical activity.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Green tea (Camellia sinensis) 1000 mg as extract
Two capsules per day; Each capsule includes Green Tea Leaf (Camellia sinensis) 5000 mg composed of 500 mg of green tea extract and 250 mg of polyphenols (epicatechin (EC), epigallocatechin (EGC), epicatechin gallato (ECG), and epigallocatechin gallato (EGCG))
Other:
Placebo
Two capsules per day; Each capsule includes 100-mg maltodextrin capsules were used as a placebo to match the color and texture of the Green tea tablets to ensure blinding.

Locations

Country Name City State
Spain Faculty of Health Sciences, University of Valladolid Soria Campus Soria

Sponsors (3)

Lead Sponsor Collaborator
University of Valladolid Instituto de Neurociencia de Castillas y Leon, Sanidad de Castilla y León

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Creatine kinase (CK) CK is an enzyme expressed by various tissues and cell types; markers of muscle damage first day of study and after 30 days of supplementation (end of study)
Primary Lactate dehydrogenase (LDH) LDH is a catalytic enzyme found in many tissues of the body;markers of muscle damage first day of study and after 30 days of supplementation (end of study)
Secondary Myoglobin (Mb) Mb is a muscle heteroprotein 1st and 30th days of the trial
Secondary Alanine Aminotransferase (ALT) markers of liver damage 1st and 30th days of the trial
Secondary Aspartate Aminotransferase (AST) markers of liver damage 1st and 30th days of the trial
Secondary Interleukin 6 (IL-6) inflammatory marker 1st and 30th days of the trial
Secondary C-reactive protein (PCR) inflammatory marker 1st and 30th days of the trial
Secondary Testosterone hormonal marker 1st and 30th days of the trial
Secondary Cortisol hormonal marker 1st and 30th days of the trial
Secondary Miostatin (GDF8) growth factor that limits the growth of muscle tissue 1st and 30th days of the trial
Secondary advanced oxidation protein products (AOPP) amino acid oxidation marker 1st and 30th days of the trial
Secondary lipid peroxidation (LPO) lipid oxidation marker 1st and 30th days of the trial
Secondary Oxygen radical absorption (ORAC) antioxidant strength marker 1st and 30th days of the trial
Secondary Total antioxidant status (TAS) antioxidant capacity marker 1st and 30th days of the trial
Secondary Total antioxidant capacity (TAC) antioxidant capacity marker 1st and 30th days of the trial
Secondary Short Physical Performance Battery (SPPB) Test evaluates three aspects of mobility 1st and 30th days of the trial
Secondary World Health Organization Quality of Life - BREF (WHOQOL-BREF) a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment 1st and 30th days of the trial
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