Impact of Whey Protein on Frailty - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in brain glutathione (GSH) levels measured using MRI scans.
研究概览
简要总结
This pilot study aims to determine the impact of whey protein supplementation on brain antioxidant levels and to assess the effects of whey protein supplementation on physical function, body composition, and cognition in pre-frail older adults.
详细描述
Frailty is characterized by weakness, muscle loss, and physical impairment. It is suggested that long term oxidative stress might contribute to frailty. Glutathione (GSH), an antioxidant in cells, is needed to combat oxidative stress. Whey protein has the potential to increase brain antioxidant (GSH) levels by aiding in antioxidant synthesis. Frail older adults under-consume protein compared to healthy older adults.
Researchers want to see if supplementing with whey protein will improve brain antioxidant status in pre-frail older adults. They will measure this by using special Magnetic Resonance Imaging (MRI) scans.
Participants will be asked to complete a total of 4 study visits, all taking place on the University of Kansas Medical Center (KUMC) main campus. Two of these visits will include an MRI scan. Participation will last about 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-frail according to Fried's phenotype
- •Age 65 to 85
- •Speak English as primary language and able to read and write in English
- •Stable medication for ≥ 30 days
- •Not already taking whey protein over the past 30 days
排除标准
- •Acute or chronic kidney disease
- •Recent major health concerns
- •Insulin-requiring diabetes
- •Cancer requiring chemotherapy or radiation within the past 5 years
- •Cardiac event (i.e., MI, etc.) in the past year
- •Dementia or neurodegenerative disease
- •Clinical trial or investigational drug or therapy participation within 30 days of the screening visit or during enrollment in the current study
- •MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)
- •Dairy Allergy or excluding dairy from diet for other reasons
- •Weight > 350 lbs.
- •The presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol (over 3 drinks/day or a total of 18 drinks/week) or drug abuse.
研究组 & 干预措施
Placebo
Participants will receive a placebo. Participants will take one serving of placebo per day.
干预措施: Placebo (Dietary Supplement)
Whey Protein
Participants will receive the dietary intervention. Participants will take one serving of whey protein per day.
干预措施: Whey Protein (Dietary Supplement)
结局指标
主要结局
Change in brain glutathione (GSH) levels measured using MRI scans.
时间窗: Changes from baseline to 3 months.
Brain GSH levels will be measured using 3T MRI scans.
次要结局
- Assess the change in physical function by measuring balance resistance, sit-to-stand, muscle strength and performance.(Changes from baseline to 3 months.)
- Assess body composition with a bioelectrical impedance analysis (BIA) device.(Changes from baseline to 3 months.)
- Assess cognition using the NIH Toolbox cognition battery.(Changes from baseline to 3 months.)