Vitamin D Contribution to Muscle Metabolic Function in Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- blood measure
研究概览
简要总结
The purpose of this study is to identify the magnitude of muscle lipid redistribution and muscle oxygen use in individuals 60 years old or older following combined treatment of vitamin D repletion and aerobic training compared to vitamin D repletion alone, aerobic training alone, or no treatment.
详细描述
The investigators plan to recruit approximately 56 aged individuals with vitamin D insufficiency for a 13 week trial. All subjects will be 60 years of age or older. Participants will be randomized to one of four groups: vitamin D (50,000IU/wk) + aerobic training (7 days during the 13th week); vitamin D (50,000IU/wk) + normal daily activity during the 13th week; placebo + aerobic training (7 days during the 13th week); or placebo + normal daily activity during the 13th week.
Following screening and informed consent process a physical activity questionnaire will be administered. A blood draw will then be conducted at baseline, midpoint and endpoint. Collected blood for the purposes of this study will assess vitamin D status (25(OH)D), parathyroid hormone, ionized calcium, insulin, and a comprehensive metabolic panel. At baseline and endpoint muscle lipid will be assessed using Magnetic Resonance Spectroscopy and muscle oxygen consumption will be determined using a novel hybrid diffuse optical instrument consisting of a near-infrared spectroscopy and a diffuse correlation spectroscopy. In addition, at each study time point 3 dietary recalls will be completed and physical activity will be measured using an accelerometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 60 and older
- •BMI: 18.5-29
- •Communicates fluently in English
排除标准
- •Metal implant not suitable for MRI
- •Any form of hormone replacement therapy
- •Engage in more than 1 hr/week of vigorous activity
- •Participated in a high-intensity resistance or aerobic training program in the last 3 months
- •Lower extremity injury or surgery in the past 3 months
- •Foot sores or bone conditions severely limiting ability to move or perform exercise or joint pain made worse by mild exercise
- •Diabetes, inflammatory bowel disease, renal disease or uncontrolled hypertension.
- •Currently have or had a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise
- •History of myopathy (including congenital myopathies)
- •History of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity
- •Past medical history of hyperparathyroidism, kidney stones or rhabdomyolysis
- •Currently receiving treatment for vitamin D deficiency
- •Vitamin D level >30ng/mL
- •Currently smoking
研究组 & 干预措施
vitamin D + aerobic training
vitamin D capsules every weekday (10,000IU/day) and exercise
干预措施: aerobic training (Other)
placebo + aerobic training
placebo capsule every weekday and exercise
干预措施: aerobic training (Other)
placebo + no aerobic training
placebo capsule every weekday and no exercise
vitamin D + aerobic training
vitamin D capsules every weekday (10,000IU/day) and exercise
干预措施: vitamin D (Dietary Supplement)
vitamin D + no aerobic training
vitamin D capsules every weekday (10,000IU/day) and no exercise
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
blood measure
时间窗: Change from Baseline in vitamin D at 13 weeks
vitamin D
次要结局
- muscle lipid(baseline and 13 weeks after baseline)
- muscle oxygen consumption(baseline and 13 weeks after baseline)
研究者
David Travis Thomas
Assistant Professor
University of Kentucky