Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

University of Aarhus

Status: Completed

Conditions: PCOS

Treatments: Dietary Supplement: water; Dietary Supplement: 3-OHB (KE4)

Study type: Interventional

Funder types: Other

Identifiers

NCT05762822

1-10-72-217-22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: water

3-OHB

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 3-OHB (KE4)