Assessing the Role of Higher Protein Diets in Managing Metabolic Complications of Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lean body mass
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a significant public health problem and is one of the most common hormonal disturbances affecting women of reproductive age. Women with PCOS are often insulin resistant, increasing their risk for cardiometabolic health problems (e.g., type 2 diabetes, heart disease, high blood pressure, sleep apnea, anxiety, depression, and stroke) especially if they are overweight. Lifestyle modifications, including dietary changes and regular physical activity, may alleviate metabolic dysfunction in women with PCOS and are often the first line of management for patients with PCOS. Several studies have identified protein as a key nutrient for regulation of energy balance, maintenance of skeletal muscle mass, and improving cardiometabolic health across the lifespan. However, the effect of increased protein intake (30% of total energy intake) on cardiometabolic health in women with PCOS has not been well-defined and mechanisms for these effects have not been identified.
There is an evident need for well-designed, randomized controlled trials evaluating the efficacy of increased protein intake in women with PCOS on markers of cardiometabolic health. Preliminary data from collaborative projects with the investigators on this proposal suggest that increasing protein in the diet has the potential to improve markers of cardiometabolic health, potentially through improvements in body composition and/or changes in cortisol, energy metabolism, inflammation, and neurological regulators
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females ages 18-50 years
- •Confirmed diagnosis of PCOS
- •Body mass index (BMI) between 18.5 and 35 kg/m2
- •Stable body weight for at least 3 months (+ 5 pounds)
- •Willingness to consume both plant- and animal-based protein meals
排除标准
- •Smoking or use of nicotine products
- •Smoking, vaping, and/or use of marijuana products
- •More than 4 alcoholic beverages per week
- •Food allergies or dietary restrictions incompatible with test meals
- •Diagnosed diabetes (type 1 or 2) or other preexisting chronic disease(s).
- •Use of medications that interfere with study outcomes (e.g., metformin, GLP-1 agonists, etc.)
- •Consumption of more than 0.8 g/protein/kg body weight
- •Underweight
- •Taking nutritional supplements
结局指标
主要结局
Lean body mass
时间窗: 0 and 16 weeks.
Lean body mass will be measured using dual x-ray absorptiometry.
次要结局
- Sleep Duration(Sleep will be measured every 8 weeks (0, 8, and 16 weeks))
- Inflammatory biomarkers(Every 4 weeks (0, 4, 8, 12, and 16 weeks).)
- Body fat mass(0 and 16 weeks)
- Mood(Every 4 weeks (0, 4, 8, 12, 16 weeks))
- Quality of Life perception(Every 4 weeks (0, 4, 8, 12, and 16 weeks))
- Energy expenditure(Every 4 weeks (0, 4, 8, 12 and 16 weeks))
- Plasma amino acid concentrations(Every 4 weeks (0, 4, 8, 12 and 16 weeks).)
- Subjective Sleep Measurements(Subjective sleep will be measured at 0, 4, 8, 12, and 16 weeks.)
研究者
Jamie Baum
Associate Professor
University of Arkansas, Fayetteville