Modulation of Sarcopenia in Older Adult Women by Green Tea Extract
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Creatine kinase (CK)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).
- •Acute/chronic heart failure with NYHA (New York Heart Association) scale >II.
- •Uncontrolled hypertension (>180/100 mm Hg).
- •Uncontrolled orthostatic hypotension.
- •Uncontrolled atrial or ventricular arrhythmias, aortic dissecting aneurysm, severe aortic stenosis, acute endocarditis/pericarditis.
- •Recent acute myocardial infarction (3 to 6 months) or unstable angina.
- •Acute thromboembolic disease.
- •Acute/chronic respiratory failure.
- •Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D.
- •Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
- •Recent bone fracture (last month).
- •History of dementia (suspected by the MAP environment and diagnosed).
- •Previous supplementation with amino acids or other nutritional compounds to improve physical performance.
- •Any other circumstance that your doctor considers prevents physical activity.
研究组 & 干预措施
Green tea supplementation group
2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal
干预措施: Green tea (Camellia sinensis) 1000 mg as extract (Dietary Supplement)
Placebo supplementation group
2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal
干预措施: Placebo (Other)
结局指标
主要结局
Creatine kinase (CK)
时间窗: 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)
时间窗: 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
次要结局
- advanced oxidation protein products (AOPP)(1st and 30th days of the trial)
- Myoglobin (Mb)(1st and 30th days of the trial)
- Testosterone(1st and 30th days of the trial)
- Miostatin (GDF8)(1st and 30th days of the trial)
- lipid peroxidation (LPO)(1st and 30th days of the trial)
- Total antioxidant capacity (TAC)(1st and 30th days of the trial)
- Aspartate Aminotransferase (AST)(1st and 30th days of the trial)
- Cortisol(1st and 30th days of the trial)
- C-reactive protein (PCR)(1st and 30th days of the trial)
- Short Physical Performance Battery (SPPB)(1st and 30th days of the trial)
- Alanine Aminotransferase (ALT)(1st and 30th days of the trial)
- Oxygen radical absorption (ORAC)(1st and 30th days of the trial)
- Interleukin 6 (IL-6)(1st and 30th days of the trial)
- Total antioxidant status (TAS)(1st and 30th days of the trial)
- World Health Organization Quality of Life - BREF (WHOQOL-BREF)(1st and 30th days of the trial)
研究者
Diego Fernandez Lazaro
Professor Doctor
University of Valladolid