Exogenous Ketone Ester in Women with Polycystic Ovary Syndrome.

NCT05762822 | Completed DMC

• 1 other identifier: 1-10-72-217-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS

Keywords

3-hydroxybutyrate; ketones; metabolism; testosterone; androgens; KetoneAid; Ketone monoester

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of testosterone

  Paired t-test

  10 hours after first intervention

Secondary Outcomes (17)

• plasma SHBG

  10 hours after first intervention

• plasma 3-OHB

  10 hours after first intervention

• plasma glucose

  10 hours after first intervention

• serum insulin

  10 hours after first intervention

• plasma C-peptide

  10 hours after first intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: water

3-OHB

ACTIVE COMPARATOR

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

Dietary Supplement: 3-OHB (KE4)

Interventions

3-OHB (KE4) DIETARY_SUPPLEMENT

60 ml (30 g) of 3-OHB

Also known as: ketone supplement

3-OHB

water DIETARY_SUPPLEMENT

60 ml water (added bitter taste)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PCOS diagnosis
• age \>18 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Diabetes and Hormone Diseases (DoH)

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Rittig N, Christiansen Arlien-Soborg M, Svart MV, Thomsen HH, Kirkegaard K, Greve VH, Nielsen MM, Stochholm K, Ornstrup MJ, Gravholt CH. Ketone supplementation acutely lowers androgen and glucose levels in women with polycystic ovary syndrome: a randomized clinical trial. Eur J Endocrinol. 2025 May 30;192(6):717-727. doi: 10.1093/ejendo/lvaf106.

  PMID: 40393075 DERIVED

MeSH Terms

Conditions

Ketosis

Interventions

Water

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Nikolaj Rittig

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 10, 2023
• Study Start: May 10, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

DK (1)