Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.
- Conditions
- PCOS
- Interventions
- Dietary Supplement: 3-OHB (KE4)Dietary Supplement: water
- Registration Number
- NCT05762822
- Lead Sponsor
- University of Aarhus
- Brief Summary
Polycystic ovarian syndrome (PCOS) is characterized by elevated androgens such as testosterone. Clinical studies suggest that ketogenic diets lower the levels of androgens. The ketone 3-hydroxybutyrate (3-OHB) may play an important role in these effects and the main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.
- Detailed Description
Polycystic ovary syndrome (PCOS) affects 5-18% of women and is characterized by the presence of two of three of the Rotterdam criteria: Hyperandrogenism (clinical or biochemical), irregular menstrual cycles, and polycystic ovary morphology, after exclusion of other conditions that mimic PCOS. PCOS is associated with elevated levels of luteinizing hormone (LH) and unaltered levels of the follicle stimulating hormone (FSH), which leads to the characteristic hyperandrogenism (high levels of testosterone), oligo- or anovulation, and a large number of premature follicles in the ovarian. Insulin resistance causes hyperinsulinemia that decreases sex hormone binding globulin (SHBG) levels and stimulates androgen production (e.g., elevated concentrations of testosterone). Ketogenic diets are characterized by a diet low in carbohydrates, and has shown beneficial effects on weight and hormonal status in women with PCOS. Whether these improvements are mediated by ketones (e.g., 3-hydroxybutyrate, 3-OHB) or other effects related to this diet is unknown. The main purpose of this study is to investigate whether a 3-OHB supplement acutely improves the hormonal and metabolic status in women with PCOS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- PCOS diagnosis
- age >18 years
- Medications affecting sex hormones (e.g. contraceptives, dopamine agonists, etc) or glucose metabolism (e.g. saxenda).
- Anemia (Hgb < 6.0 mM)
- Practicing ketogenic diets (e.g., low-carb diet, fasting regimes)
- Inability to understand Danish or English
- Diabetes
- Ongoing cancer or other acute/chronic serious diseases (PI will determine)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 3-OHB 3-OHB (KE4) 60 ml 3-OHB (30 g) at 10 pm the night before and 6 am on the day for blood sampling (8 am). Placebo water 60 ml water (same taste as active comparator) at 10 pm the night before and 6 am on the day for blood sampling (8 am).
- Primary Outcome Measures
Name Time Method Plasma concentration of testosterone 10 hours after first intervention Paired t-test
- Secondary Outcome Measures
Name Time Method plasma 3-OHB 10 hours after first intervention plasma SHBG 10 hours after first intervention plasma C-peptide 10 hours after first intervention plasma triglycerides 10 hours after first intervention plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163) 10 hours after first intervention plasma prolactin 10 hours after first intervention plasma free testosterone 10 hours after first intervention plasma free fatty acids 10 hours after first intervention Plasma FSH 10 hours after first intervention plasma glucose 10 hours after first intervention Plasma LH 10 hours after first intervention serum insulin 10 hours after first intervention plasma cholesterol 10 hours after first intervention C reactive protein 10 hours after first intervention plasma estradiol 10 hours after first intervention plasma keto-testosterone 10 hours after first intervention Homeostatic Model Assessment for Insulin Resistance 10 hours after first intervention
Trial Locations
- Locations (1)
Department of Diabetes and Hormone Diseases (DoH)
🇩🇰Aarhus N, Denmark