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Effect of Green Tea Supplementation in Older Adult Women

Modulation of Sarcopenia in Older Adult Women by Green Tea Extract

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06289439
Acronym
GTAW
Enrollment
120
Registered
2024-03-01
Start date
2024-03-05
Completion date
2025-04-01
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female, Older Adults, Sarcopenia

Keywords

sarcopenia, green tea, exercise, quality of life, physical performance, health biomarkers

Brief 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).

Interventions

DIETARY_SUPPLEMENTGreen 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))

OTHERPlacebo

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.

Sponsors

Sanidad de Castilla y León
CollaboratorOTHER
Instituto de Neurociencia de Castillas y Leon
CollaboratorOTHER
University of Valladolid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Parallel group placebo-controlled randomized clinical trial

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Creatine kinase (CK)first day of study and after 30 days of supplementation (end of study)CK is an enzyme expressed by various tissues and cell types; markers of muscle damage
Lactate dehydrogenase (LDH)first day of study and after 30 days of supplementation (end of study)LDH is a catalytic enzyme found in many tissues of the body;markers of muscle damage

Secondary

MeasureTime frameDescription
Aspartate Aminotransferase (AST)1st and 30th days of the trialmarkers of liver damage
Interleukin 6 (IL-6)1st and 30th days of the trialinflammatory marker
C-reactive protein (PCR)1st and 30th days of the trialinflammatory marker
Testosterone1st and 30th days of the trialhormonal marker
Cortisol1st and 30th days of the trialhormonal marker
Miostatin (GDF8)1st and 30th days of the trialgrowth factor that limits the growth of muscle tissue
Myoglobin (Mb)1st and 30th days of the trialMb is a muscle heteroprotein
lipid peroxidation (LPO)1st and 30th days of the triallipid oxidation marker
Oxygen radical absorption (ORAC)1st and 30th days of the trialantioxidant strength marker
Total antioxidant status (TAS)1st and 30th days of the trialantioxidant capacity marker
Total antioxidant capacity (TAC)1st and 30th days of the trialantioxidant capacity marker
Short Physical Performance Battery (SPPB)1st and 30th days of the trialTest evaluates three aspects of mobility
World Health Organization Quality of Life - BREF (WHOQOL-BREF)1st and 30th days of the triala self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment
advanced oxidation protein products (AOPP)1st and 30th days of the trialamino acid oxidation marker
Alanine Aminotransferase (ALT)1st and 30th days of the trialmarkers of liver damage

Countries

Spain

Contacts

Primary ContactDiego Fernández Lázaro, Professor; PhD
diego.fernandez.lazaro@uva.es+34658073375
Backup ContactCésar Ignacio Fernández Lázaro, Professor; PhD
fernandezlazaro@usal.es658073375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026