Effect of Green Tea Supplementation in Older Adult Women

Sarcopenia Clinical Trial

— GTAW  

Official title:

Modulation of Sarcopenia in Older Adult Women by Green Tea Extract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289439
• Other study ID #: 2024.05.25
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Female
• Older Adults
• Sarcopenia

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