Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Ovulatory Status
研究概览
简要总结
The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS).
Participants will be randomly assigned to one of two groups:
- A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.
- A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement.
The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health.
This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.
详细描述
The SPARK study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week randomized, two-arm intervention examining how nutritional ketosis influences ovulatory and metabolic outcomes in women with Polycystic Ovary Syndrome (PCOS).
PCOS is a common endocrine disorder that affects hormone balance, menstrual function, and metabolism. Current treatments often address single symptoms but rarely provide comprehensive improvement. Ketogenic dietary interventions have shown promise for improving insulin sensitivity, hormone profiles, and body composition; however, few studies have evaluated their direct impact on ovulation.
In this pilot trial, 40 women aged 18-40 years with diagnosed PCOS will be randomized to one of two groups:
Ketogenic Diet (KD): Participants will follow a low-carbohydrate, high-fat, moderate-protein diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L).
Mixed Diet + Exogenous Ketone Supplement: Participants will consume a balanced diet aligned with USDA macronutrient recommendations and receive a ketone ester supplement.
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
- None
盲法说明
This is a pilot feasibility study; therefore, no masking will be implemented. Participants and investigators will be aware of group assignments due to the distinct nature of the dietary and supplement interventions. The study is designed as an open-label trial to evaluate adherence, feasibility, and physiological responses to each intervention before planning a larger randomized, controlled study.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-40 years.
- •Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound).
- •Willingness and ability to comply with all study procedures, including fasting (>10 hours; water only), avoidance of alcohol (>24 hours), and abstaining from exercise (>24 hours) prior to each test visit.
- •Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.
- •Body mass index (BMI) ≥18 kg/m².
- •Access to a smartphone, computer, or tablet for digital tracking and study communication.
排除标准
- •Current adherence to a low-carbohydrate diet (<30% of total energy from carbohydrates).
- •Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).
- •History of type 1 diabetes or uncontrolled type 2 diabetes.
- •Weight loss ≥10% of body weight within the previous 6 months.
- •Pregnancy or breastfeeding.
- •Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment.
- •Active eating disorder or medical condition that could interfere with dietary intervention.
- •Any condition that, in the opinion of the Investigator, could interfere with participation, data integrity, or safety.
研究组 & 干预措施
Ketogenic Diet (KD)
Participants in this arm will follow a well-formulated ketogenic diet designed to achieve and maintain nutritional ketosis (β-hydroxybutyrate ≥0.5 mmol/L). The diet will include non-starchy vegetables as the primary carbohydrate source (20-50 g/day), moderate protein (1.2-1.6 g/kg/day), and sufficient fat for energy and satiety. All meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with support from the study dietitian and educational resources. Daily fingerstick ketone and glucose levels will be monitored using KetoMojo.
干预措施: Ketogenic diet (Other)
Mixed Diet + Exogenous Ketone Supplement
Participants in this arm will follow a balanced, mixed diet aligned with USDA macronutrient recommendations while consuming an exogenous ketone supplement throughout the 12-week intervention. The supplement is designed to raise circulating β-hydroxybutyrate to nutritional ketosis levels without carbohydrate restriction. As with the KD arm, all meals and snacks will be provided for the first 2 weeks, followed by self-guided adherence with ongoing dietitian support.
干预措施: Exogenous Ketone Supplement (Dietary Supplement)
结局指标
主要结局
Change in Ovulatory Status
时间窗: Baseline to 12 weeks
To evaluate whether ketogenic dietary intervention or exogenous ketone supplementation restores ovulatory function in women with Polycystic Ovary Syndrome (PCOS). Ovulatory status will be assessed using a combination of validated measures, including basal body temperature monitoring via BBT, urinary luteinizing hormone (LH) surge detection using ovulation predictor kits, and serum progesterone levels. Participants will be classified as ovulatory or anovulatory based on hormonal and temperature cycle confirmation.
次要结局
- Change in Serum Progesterone Concentration (ng/mL)(Baseline to 12 weeks)
- Change in Serum Estradiol Concentration (pg/mL)(Baseline to 12 weeks)
- Change in Serum Luteinizing Hormone Concentration (mIU/mL)(Baseline to 12 weeks)
- Change in Serum Follicle Stimulating Hormone Concentrations (mIU/mL)(Baseline to 12 weeks)
- Change in Daily Fasting BHB (mmol/L)(Baseline to 12 weeks (Daily))
- Change in Daily Fasting Glucose (mg/dL)(Baseline to 12 weeks (Daily))
- Change in Serum Insulin Concentration (µIU/mL)(Baseline to 12 weeks)
- Change in Serum Total Cholesterol Concentration (mg/dL)(Baseline to 12 weeks)
- Change in Serum Triglyceride Concentration (mg/dL)(Baseline to 12 weeks)
- Change in Serum LDL Cholesterol Concentration (mg/dL)(Baseline to 12 weeks)
- Change in Serum HDL Cholesterol Concentration (mg/dL)(Baseline to 12 weeks)
研究者
Madison Kackley
Assistant Professor
Ohio State University