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Effect of Green Tea Supplementation in Older Adult Women

Not Applicable
Recruiting
Conditions
Older Adults
Sarcopenia
Female
Interventions
Dietary Supplement: Green tea (Camellia sinensis) 1000 mg as extract
Other: Placebo
Registration Number
NCT06289439
Lead Sponsor
University of Valladolid
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
120
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Green tea supplementation groupGreen tea (Camellia sinensis) 1000 mg as extract2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal
Placebo supplementation groupPlacebo2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
advanced oxidation protein products (AOPP)1st and 30th days of the trial

amino acid oxidation marker

C-reactive protein (PCR)1st and 30th days of the trial

inflammatory marker

Myoglobin (Mb)1st and 30th days of the trial

Mb is a muscle heteroprotein

Testosterone1st and 30th days of the trial

hormonal marker

Miostatin (GDF8)1st and 30th days of the trial

growth factor that limits the growth of muscle tissue

lipid peroxidation (LPO)1st and 30th days of the trial

lipid oxidation marker

Total antioxidant capacity (TAC)1st and 30th days of the trial

antioxidant capacity marker

Aspartate Aminotransferase (AST)1st and 30th days of the trial

markers of liver damage

Cortisol1st and 30th days of the trial

hormonal marker

Short Physical Performance Battery (SPPB)1st and 30th days of the trial

Test evaluates three aspects of mobility

Alanine Aminotransferase (ALT)1st and 30th days of the trial

markers of liver damage

Oxygen radical absorption (ORAC)1st and 30th days of the trial

antioxidant strength marker

Interleukin 6 (IL-6)1st and 30th days of the trial

inflammatory marker

Total antioxidant status (TAS)1st and 30th days of the trial

antioxidant capacity marker

World Health Organization Quality of Life - BREF (WHOQOL-BREF)1st and 30th days of the trial

a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment

Trial Locations

Locations (1)

Faculty of Health Sciences, University of Valladolid Soria Campus

🇪🇸

Soria, Spain

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