Effects of Creatine Supplementation on Muscle Mass and Function Among Older Women Subjected to Resistance Training
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rectus Femoris Cross Sectional Height
研究概览
简要总结
To determine, in a double blind trial, the effects of creatine supplementation during 12 weeks on muscle mass and function of community living older women subjected to resistance training. Material and methods: Fifty healthy older women will be selected for the study. All participants will be subjected to a progressive resistance training program using elastic bands and weights, consisting in three sessions per week lasting 1 hour. Participant will be randomly allocated in a double blind fashion, to receive creatine 5 g per day or an identical placebo. The training and supplementation period will last 12 weeks. At baseline and at the end of the study, body composition will be measured by dual energy x-ray absorptiometry, rectus femoris cross sectional height and surface will be measured by ultrasound, quadriceps strength will be measured in a quadriceps table and 12 minutes' walk will be assessed. The main outcome measure will be quadriceps cross sectional height. Expected results: We expect that creatine supplementation will increase rectus femoris height over and above the effect of resistance training.
详细描述
Healthy women of middle and low socioeconomic level, living in the community and aged between 60 and 75 years, will be invited to participate in this study.
At baseline and after signing an informed consent form, the following assessments will be carried out:
- A complete medical history including medications, previous diseases and surgical procedures.
- Evaluation of usual physical activity using the International Physical Activity Questionnaire (IPAQ) .
- Minimental state examination .
- Mininutritional assessment .
- Measurement of weight, height, waist and hip circumference.
- Measurement of body composition by double energy X ray absorptiometry in a General Electric iDEXA equipment.
- Measurement of rectus femoris cross sectional height using a General Electric LogiQ ultrasonographer. Measurements will be made with the participant in supine position and the tight relaxed. The mid-point between the superior anterior iliac spine and the superior border to the patella will be the measurement point.
- Measurement of quadriceps isometric force using a quadriceps table as previously described .
- Measurement of hand grip strength using a hand grip dynamometer.
- Measurement of 12 minutes walking capacity .
After performing the baseline assessment, participants will be randomized in one of two groups, balancing by age and nutritional status, using a double blind design:
- The active group will receive creatine 5 g/day in one dose as a powder to be dissolved in water
- The control group will receive a placebo of similar aspect and taste as creatine.
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
- Quadruple (Participant, Care Provider, 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
- •Absence of a significant disability, defined as the capacity to reach the health center by their own means with the use of any aid such as canes or wheelchairs
- •Absence of disabling diseases such as cardiac, respiratory, liver or kidney failure or active cancer
- •Absence of decompensated diabetes mellitus of hypertension. Diabetic patients with repeated fasting blood glucose levels below 120 mg/dl and a glycosylated hemoglobin below 7% will be allowed to participate. Hypertensive patients in treatment with a blood pressure (measured in at least two occasions) below 140/90 mm Hg will also be allowed.
排除标准
- •Smoking or excessive consumption of alcohol
- •Use of medications that can cause muscle dysfunction or limit exercise capacity such as adrenal steroids, chemotherapeutic agents, statins in high doses (ie more than 40 mg/day of atorvastatin) or muscle relaxants.
- •Having a severe osteoarticular disease such as rheumatoid arthritis or severe osteoarthritis, with precludes participating in an exercise training program.
- •Recent use of ergogenic supplements such as creatine.
- •Being engaged in an active exercise training program.
- •Being illiterate or having a level of cognitive dysfunction that precludes the free signature of a written informed consent to participate in the study.
- •Any personal or socioeconomic condition that, in opinion of the research team, will hamper the correct compliance of the participant with the research program.
研究组 & 干预措施
Creatine
Creatine 5 g/ day
干预措施: Resistance exercise training (Other)
Creatine
Creatine 5 g/ day
干预措施: Creatine (Drug)
Placebo
Maltodextrin 5 g/day to be dissolved in water
干预措施: Resistance exercise training (Other)
结局指标
主要结局
Rectus Femoris Cross Sectional Height
时间窗: Twelve weeks
Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound
次要结局
- Twelve Minutes Walk(Twelve weeks)
- Quadriceps Isometric Strength(Twelve weeks)
研究者
Daniel Bunout
Medical Doctor
University of Chile