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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).

60 ml 3-OHB (30 g) at 10 pm the night before and 6 am on the day for blood sampling (8 am).

3-OHB (KE4)

water

Nikolaj Rittig, PhD

Nikolaj Rittig, MD, PhD

Nikolaj Rittig

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.

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.

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.

Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

University of Aarhus

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.	NCT05762822	PCOS	3-OHB (KE4) water	18 Years -	University of Aarhus
Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.	NCT05762822	PCOS	3-OHB (KE4) water	18 Years -	University of Aarhus

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