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Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

Primary Purpose

PCOS

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3-OHB (KE4)
water
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring 3-hydroxybutyrate, ketones, metabolism, testosterone, androgens, KetoneAid, Ketone monoester

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Diabetes and Hormone Diseases (DoH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

3-OHB

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Plasma concentration of testosterone
Paired t-test

Secondary Outcome Measures

plasma SHBG
plasma 3-OHB
plasma glucose
serum insulin
plasma C-peptide
plasma free fatty acids
plasma triglycerides
plasma cholesterol
C reactive protein
plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)
plasma prolactin
Plasma FSH
Plasma LH
plasma free testosterone
plasma estradiol
plasma keto-testosterone
Homeostatic Model Assessment for Insulin Resistance

Full Information

First Posted
February 15, 2023
Last Updated
August 7, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05762822
Brief Title
Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.
Official Title
Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS
Keywords
3-hydroxybutyrate, ketones, metabolism, testosterone, androgens, KetoneAid, Ketone monoester

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Power calculation resulted in n=18 for the primary endpoint. We plan to include n=30 to ensure statistical power and take dropouts, missing values etc into account.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
3-OHB
Arm Type
Active Comparator
Arm Description
60 ml 3-OHB (30 g) at 10 pm the night before and 6 am on the day for blood sampling (8 am).
Intervention Type
Dietary Supplement
Intervention Name(s)
3-OHB (KE4)
Other Intervention Name(s)
ketone supplement
Intervention Description
60 ml (30 g) of 3-OHB
Intervention Type
Dietary Supplement
Intervention Name(s)
water
Intervention Description
60 ml water (added bitter taste)
Primary Outcome Measure Information:
Title
Plasma concentration of testosterone
Description
Paired t-test
Time Frame
10 hours after first intervention
Secondary Outcome Measure Information:
Title
plasma SHBG
Time Frame
10 hours after first intervention
Title
plasma 3-OHB
Time Frame
10 hours after first intervention
Title
plasma glucose
Time Frame
10 hours after first intervention
Title
serum insulin
Time Frame
10 hours after first intervention
Title
plasma C-peptide
Time Frame
10 hours after first intervention
Title
plasma free fatty acids
Time Frame
10 hours after first intervention
Title
plasma triglycerides
Time Frame
10 hours after first intervention
Title
plasma cholesterol
Time Frame
10 hours after first intervention
Title
C reactive protein
Time Frame
10 hours after first intervention
Title
plasma cytokines (such as Tumor Necrotic Factor alpha, Interleukin 6, Lipopolysaccharide -binding protein, soluble CD163)
Time Frame
10 hours after first intervention
Title
plasma prolactin
Time Frame
10 hours after first intervention
Title
Plasma FSH
Time Frame
10 hours after first intervention
Title
Plasma LH
Time Frame
10 hours after first intervention
Title
plasma free testosterone
Time Frame
10 hours after first intervention
Title
plasma estradiol
Time Frame
10 hours after first intervention
Title
plasma keto-testosterone
Time Frame
10 hours after first intervention
Title
Homeostatic Model Assessment for Insulin Resistance
Time Frame
10 hours after first intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolaj Rittig, PhD
Phone
+45 61714731
Email
nikolaj.rittig@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaj Rittig
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Diabetes and Hormone Diseases (DoH)
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolaj Rittig, MD, PhD
Phone
+45 61714731
Email
nikolaj.rittig@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Nikolaj Rittig, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Exogenous Ketone Ester in Women With Polycystic Ovary Syndrome.

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