Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

PCOS Clinical Trial

Official title:

Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762822
• Other study ID #: 1-10-72-217-22
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: Nikolaj Rittig, PhD
• Phone: +45 61714731
• Email: nikolaj.rittig[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• 3-OHB (KE4)
60 ml (30 g) of 3-OHB
• water
60 ml water (added bitter taste)

Locations

Country	Name	City	State
Denmark	Department of Diabetes and Hormone Diseases (DoH)	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of testosterone	Paired t-test	10 hours after first intervention
Secondary	plasma SHBG		10 hours after first intervention
Secondary	plasma 3-OHB		10 hours after first intervention
Secondary	plasma glucose		10 hours after first intervention
Secondary	serum insulin		10 hours after first intervention
Secondary	plasma C-peptide		10 hours after first intervention
Secondary	plasma free fatty acids		10 hours after first intervention
Secondary	plasma triglycerides		10 hours after first intervention
Secondary	plasma cholesterol		10 hours after first intervention
Secondary	C reactive protein		10 hours after first intervention
Secondary	plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)		10 hours after first intervention
Secondary	plasma prolactin		10 hours after first intervention
Secondary	Plasma FSH		10 hours after first intervention
Secondary	Plasma LH		10 hours after first intervention
Secondary	plasma free testosterone		10 hours after first intervention
Secondary	plasma estradiol		10 hours after first intervention
Secondary	plasma keto-testosterone		10 hours after first intervention
Secondary	Homeostatic Model Assessment for Insulin Resistance		10 hours after first intervention