Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

Last updated: October 31, 2024
Sponsor: University of Aarhus
Overall Status: Completed

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

3-OHB (KE4)

water

Clinical Study ID

NCT05762822
1-10-72-217-22
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PCOS diagnosis

  • age >18 years

Exclusion

Exclusion Criteria:

  • Medications affecting sex hormones (e.g. contraceptives, dopamine agonists, etc) orglucose 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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: 3-OHB (KE4)
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
October 30, 2024

Study 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.

Connect with a study center

  • Department of Diabetes and Hormone Diseases (DoH)

    Aarhus N, 8200
    Denmark

    Site Not Available

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