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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05762822
Other study ID # 1-10-72-217-22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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