The Effect of Menstrual Phase and Oral Contraceptives on Muscle Protein Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
研究概览
简要总结
Despite comprising half the population, females are often left out of muscle research due to the impact of changing hormones during the menstrual cycle and when using oral contraceptives. This makes it hard to perform costly and invasive studies involving tracers to study muscle protein metabolism. Consequently, we lack a clear understanding of how these hormonal changes affect muscle growth.
There is a need for less invasive methods to study how sex hormones and oral contraceptives influence muscle protein metabolism. Ex vivo models, where serum from participants is applied to mouse muscle cell cultures, mimic the conditions of human muscle cells and can provide initial insights.
详细描述
The aim of the study is to develop a non-invasive model using serum from both oral contraceptive users and non-users at various stages of their cycles, to understand if different cycle or pill stages affect how muscles process proteins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5-29.9 kg/m2 (I.e., non-obese).
- •For OC users: on monophasic OCs for > 3 months prior to study enrollment
- •For non-OC users: regular menstrual cycles length (25-35 days) for at least 3 months prior to study and at least 6 months off of OCs.
排除标准
- •Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
- •Current or recent remission of cancer
- •Regular use of NSAID (except low-dose aspirin), anticoagulants
- •Use of prescription drugs that would impact metabolism, e.g. Statins, Lithium, Attention-Deficit/Hyperactivity Disorder (ADHD) medication.
- •Insertion of intrauterine device (IUD) - exception: copper
- •Use of ergogenic aids such as creatine
- •Regular Tabacco use
- •Use of illicit drugs (growth hormones, testosterone)
- •For non-OC users: Use of oral contraceptives for > 6 months prior to study enrollment - to ensure return to regular menstrual cycle.
结局指标
主要结局
Protein Synthesis (Murine Cell-Based Experiments, ex-vivo experiments)
时间窗: 60 minutes
Investigators will use human serum obtained from fasted and fed timepoints (-15, 20, 40 and 60 minutes following beverage consumption) to condition cell culture media (20% volume). To determine the effects of using fasted and/or fed 'human-conditioned' culture media on cell protein synthesis, puromycin incorporation (measure of protein synthesis) will be measured via western blot and expressed relative to a no-serum control. A two-way repeated measures ANOVA will be used to analyze outcomes with cycle stage and group (OC vs non-OC) used as factors
次要结局
- Whole-body protein synthesis(6 hours)
- Urinary Measures (Muscle Protein Breakdown)(6 hours)
研究者
Daniel Moore
Associate Professor
University of Toronto