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OpenTrials
Completed

NCT Number: NCT05762822

Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Diabetes and Hormone Diseases (DoH)

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3-OHB (KE4)

Dietary Supplement

60 ml (30 g) of 3-OHB

Other names: ketone supplement

Water

Dietary Supplement

60 ml water (added bitter taste)

Primary outcomes

  1. Plasma concentration of testosterone

    Time frame: 10 hours after first intervention

    Paired t-test

Secondary outcomes

  1. plasma SHBG

    Time frame: 10 hours after first intervention

  2. plasma 3-OHB

    Time frame: 10 hours after first intervention

  3. plasma glucose

    Time frame: 10 hours after first intervention

  4. serum insulin

    Time frame: 10 hours after first intervention

  5. plasma C-peptide

    Time frame: 10 hours after first intervention

  6. plasma free fatty acids

    Time frame: 10 hours after first intervention

  7. plasma triglycerides

    Time frame: 10 hours after first intervention

  8. plasma cholesterol

    Time frame: 10 hours after first intervention

  9. C reactive protein

    Time frame: 10 hours after first intervention

  10. plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)

    Time frame: 10 hours after first intervention

  11. plasma prolactin

    Time frame: 10 hours after first intervention

  12. Plasma FSH

    Time frame: 10 hours after first intervention

  13. Plasma LH

    Time frame: 10 hours after first intervention

  14. plasma free testosterone

    Time frame: 10 hours after first intervention

  15. plasma estradiol

    Time frame: 10 hours after first intervention

  16. plasma keto-testosterone

    Time frame: 10 hours after first intervention

  17. Homeostatic Model Assessment for Insulin Resistance

    Time frame: 10 hours after first intervention

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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