Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-10-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Power calculation resulted in n=18 for the primary endpoint. We plan to include n= 20 to ensure statistical power and take dropouts, missing values etc into account.

Washout period of minimum 3 days.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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).

Group Type PLACEBO_COMPARATOR

water

Intervention Type DIETARY_SUPPLEMENT

60 ml water (added bitter taste)

3-OHB

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

Group Type ACTIVE_COMPARATOR

3-OHB (KE4)

Intervention Type DIETARY_SUPPLEMENT

60 ml (30 g) of 3-OHB

Interventions

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3-OHB (KE4)

60 ml (30 g) of 3-OHB

Intervention Type DIETARY_SUPPLEMENT

water

60 ml water (added bitter taste)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ketone supplement

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No