Clinical trial NCT06289439: Effect of Green Tea Supplementation in Older Adult Women
Official title: Modulation of Sarcopenia in Older Adult Women by Green Tea Extract
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female
Older Adults
Sarcopenia
Keywords: sarcopenia
green tea
exercise
quality of life
physical performance
health biomarkers
Lead sponsor: University of Valladolid
Sponsor class: OTHER
Collaborators: name: Sanidad de Castilla y León
name: Instituto de Neurociencia de Castillas y Leon
First posted: 2024-03-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group placebo-controlled randomized clinical trial
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Creatine kinase (CK)
timeFrame: first day of study and after 30 days of supplementation (end of study)
measure: Lactate dehydrogenase (LDH)
timeFrame: first day of study and after 30 days of supplementation (end of study)
Secondary outcomes:
measure: Myoglobin (Mb)
timeFrame: 1st and 30th days of the trial
measure: Alanine Aminotransferase (ALT)
timeFrame: 1st and 30th days of the trial
measure: Aspartate Aminotransferase (AST)
timeFrame: 1st and 30th days of the trial
measure: Interleukin 6 (IL-6)
timeFrame: 1st and 30th days of the trial
measure: C-reactive protein (PCR)
timeFrame: 1st and 30th days of the trial
measure: Testosterone
timeFrame: 1st and 30th days of the trial
measure: Cortisol
timeFrame: 1st and 30th days of the trial
measure: Miostatin (GDF8)
timeFrame: 1st and 30th days of the trial
measure: advanced oxidation protein products (AOPP)
timeFrame: 1st and 30th days of the trial
measure: lipid peroxidation (LPO)
timeFrame: 1st and 30th days of the trial
measure: Oxygen radical absorption (ORAC)
timeFrame: 1st and 30th days of the trial
measure: Total antioxidant status (TAS)
timeFrame: 1st and 30th days of the trial
measure: Total antioxidant capacity (TAC)
timeFrame: 1st and 30th days of the trial
measure: Short Physical Performance Battery (SPPB)
timeFrame: 1st and 30th days of the trial
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: 1st and 30th days of the trial
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Faculty of Health Sciences, University of Valladolid Soria Campus
Study officials:
References: