Comparing the Effects of Three PROtein-enhancement Strategies on Exercise-induced Muscle Damage in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- serum creatine kinase (CK) levels
研究概览
简要总结
The goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. The main question it aims to answer is:
What is the effect of three different protein-enhancement strategies (whey protein (WP), mixed plant-based protein (MPP), and use of protein-rich food products (PFP) on exercise-induced muscle damage in older adults compared to isocaloric carbohydrate control?
Participants will:
- Use a protein-enhancement strategy (WP, MPP or PFP) or carbohydrate control for a total of 5 weeks;
- Participate in a single walking bound (30/40/50 km) two weeks after the start of the study;
- Participate in a consecutive walking bound (4 days of 30/40/50 km) in the last week of the study period;
- Complete different questionnaires and give blood samples to test for muscle damage.
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
- Double (Participant, Investigator)
盲法说明
The study consists of 4 arms of which 3 arms that receive a supplement and 1 arm that will use an e-health application to enhance protein intake. The 3 supplement arms are double-blind. The e-health arm is not; since it is not possible to blind either the participants in this group neither the investigators.
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
- •60 years or older
- •Registered for the Nijmegen Four Days Marches (i.e., able to walk 30-50 km/day)
- •A habitual protein intake <1.0 g/kg/d based on the protein 55+ (PRO55+) screening tool
- •Able to understand and perform the study procedures
- •Able to use a mobile device
排除标准
- •Allergic or sensitive for milk proteins, or lactose intolerant
- •Diagnosed type I or type II diabetes mellitus
- •Diagnosed intestinal diseases influencing the uptake of protein (i.e., active inflammatory bowel disease, Crohn's disease)
- •Consumption of other freely available protein supplements during the study period.
- •If the subject intends to perform additional exercise bouts that cause muscle damage in the 4 days before the single- and multiple exercise bouts.
结局指标
主要结局
serum creatine kinase (CK) levels
时间窗: Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise)
Exercise-induced muscle damage. Non-fasted venous blood samples will be drawn from the antecubital vein at each pre-exercise and post-exercise visit. Based on previous research it is expected that time-dependent exercise-induced increase in creatine kinase (CK) levels are significantly different between protein groups and control, but not within protein groups. Multiple peak post-exercise CK concentrations (several hours to up to 48h post exercise) will be compared to pre-exercise CK levels to compare the effect of different protein enhancing strategies versus carbohydrate control.
次要结局
- muscle soreness(Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise))
- muscle function(Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise))
- serum lactate dehydrogenase (LDH) levels(Measured 8 times in total. Once pre-single exercise, two times post-single exercise (within 2h after and around 24h after) and 2 weeks later: once pre-multiple day exercise and four times post-multiple day exercise (within 2h post-exercise))