Effect of Green Tea Supplementation in Older Adult Women (GTAW)

University of Valladolid (UVA)

Status: Enrolling

Conditions: Female; Older Adults; Sarcopenia

Treatments: Dietary Supplement: Green tea (Camellia sinensis) 1000 mg as extract; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06289439

2024.05.25

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Green tea supplementation group

Experimental group

Description:

2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal

Treatment:

Dietary Supplement: Green tea (Camellia sinensis) 1000 mg as extract

Placebo supplementation group

Placebo Comparator group

Description:

2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal

Treatment:

Other: Placebo