PCOS
Conditions
Keywords
3-hydroxybutyrate, ketones, metabolism, testosterone, androgens, KetoneAid, Ketone monoester
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.
Interventions
DIETARY_SUPPLEMENT3-OHB (KE4)
60 ml (30 g) of 3-OHB
DIETARY_SUPPLEMENTwater
60 ml water (added bitter taste)
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Power calculation resulted in n=18 for the primary endpoint. We plan to include n= 20 to ensure statistical power and take dropouts, missing values etc into account. Washout period of minimum 3 days.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PCOS diagnosis * age \>18 years
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of testosterone | 10 hours after first intervention | Paired t-test |
Secondary
| Measure | Time frame |
|---|---|
| plasma 3-OHB | 10 hours after first intervention |
| plasma glucose | 10 hours after first intervention |
| serum insulin | 10 hours after first intervention |
| plasma C-peptide | 10 hours after first intervention |
| plasma free fatty acids | 10 hours after first intervention |
| plasma triglycerides | 10 hours after first intervention |
| plasma cholesterol | 10 hours after first intervention |
| C reactive protein | 10 hours after first intervention |
| plasma SHBG | 10 hours after first intervention |
| plasma prolactin | 10 hours after first intervention |
| Plasma FSH | 10 hours after first intervention |
| Plasma LH | 10 hours after first intervention |
| plasma free testosterone | 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 |
| plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163) | 10 hours after first intervention |
Countries
Denmark
Outcome results
None listed