Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in 'Objectively assessed whole body function'
研究概览
简要总结
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly.
50 participants will be given a food supplement to take for 12 weeks; this supplement will either be creatine or a placebo (a regular fruit flavoured powder that has no benefits).
Over 12 weeks, body fat and muscle size (body composition), physical function, and fitness (aerobic capacity of the heart and lungs to transport oxygen to the exercising muscles) will be tested. In addition, quality of life questionnaires will be completed, disease activity will be assessed and blood samples will be taken. Muscle samples (muscle biopsy) will be obtained, from those who volunteer to provide them, at baseline and post-treatment.
详细描述
Background and aims
Rheumatoid arthritis (RA) patients typically experience a significant loss of muscle. This reduces their ability to complete daily tasks and increases disability, as well as increasing the risk to infection and other illness.
Exercise is most effective for increasing muscle size and strength, but it is time consuming, expensive and hard work, meaning uptake is poor. So, widely acceptable alternatives are required.
The study aims to test a food supplement called creatine. Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.
The creatine will be provided as a fruit flavoured powder that participants will mix with water and drink, much like a fruit squash. In healthy individuals, food supplementation with creatine (Cr) increases muscle size and improves physical function and quality of life. The aim of this study is to investigate whether RA patients may benefit similarly
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfil the American Rheumatism Association 1987 revised criteria for the diagnosis of RA
- •be functional class I or II
- •be age 18 years or over
排除标准
- •be cognitively impaired; (b) have any other cachectic diseases and any condition preventing safe participation in the study
- •have a glomerular filtration rate above 60mL/min/1.73m2, assessed from medical records, and no other evidence of kidney damage
- •be taking drugs or other nutritional supplements known to increase muscle mass
- •be participating in regular and intense physical training program be pregnant
结局指标
主要结局
Change in 'Objectively assessed whole body function'
时间窗: Measured at Baseline, Day 6, Week 12, Week 24
Physical function will be assessed using the following tests: 1. strength tests of the knee muscles and hand-grip 2. the Up-and-Go Test (UG) - For the UG, participants are required rise from a seated position on a fixed chair, walk forward to a cone placed 8ft (2.44 m) away, and return to the chair and a seated position. 3. the sit-to-stand in 30 sec test (SST-30) - For the SST-30 participants will rise from the same seated position as during the UG as many times as possible in 30 s whilst keeping their arms folded across the chest. 4. 50-ft walk test - During the 50-ft walk test, time taken to complete the walk along a straight line marked by cones is recorded 5. To assess fitness participants will complete the Siconolfi step test.
次要结局
- Change in body composition(Baseline, Day 6, Week 12, Week 24)
研究者
Thomas James Wilkinson
PhD Research Student
Bangor University