Ketogenic DietKETO-THYROIDNCT07775326
Dietary Macronutrients and Metabolic Markers
A study testing Ketogenic diet in people with Ketogenic Diet and Thyroid Function, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
This prospective 12-week dietary intervention study evaluated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years across different adiposity categories. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Diet, Thyroid Function, Insulin Resistance
- What is being tested?
- Ketogenic diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 3 Mar 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal status
- No use of a specific diet, calorie-restricted diet, or food-elimination regimen during the preceding 12 months
- Willingness to follow the prescribed ketogenic diet for 12 weeks
- Provision of written informed consent
Who cannot join
- Postmenopausal status
- Pregnancy or breastfeeding
- Previously diagnosed thyroid disease
- Thyroid hormone replacement therapy
- Use of antithyroid medication
- Use of other pharmacological treatments known to substantially affect thyroid function
Show all 9Show fewer
- Use of dietary supplements known to substantially affect glucose or lipid metabolism before enrollment
- Use of pharmacological treatment for insulin resistance
- Use of pharmacological treatment for dyslipidemia
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Katowice, 40-065
About this study
Official title: Effects of a 12-Week Ketogenic Diet on Thyroid Function and Glucose-Insulin Metabolism in Premenopausal Women Across Different Adiposity Categories
This prospective 12-week dietary intervention study evaluated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years across different adiposity categories. Participants followed an individualized low-carbohydrate ketogenic diet designed to induce and maintain nutritional ketosis. Thyroid-related outcomes included thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4). Glucose-insulin metabolism was assessed using fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), and the homeostatic model assessment of insulin resistance (HOMA-IR). Changes in body mass and anthropometric parameters were also evaluated. Outcomes were assessed before and after the 12-week intervention and compared according to baseline BMI categories.
Read the detailed description
This prospective, single-group, 12-week dietary intervention study investigated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years. Participants were classified according to baseline BMI into normal-weight, overweight, and obesity categories for analytical purposes. All participants received the same ketogenic dietary intervention; BMI categories did not represent separate intervention arms.
The ketogenic diet was individually prescribed and characterized by very low carbohydrate intake, moderate protein intake, and a high proportion of dietary fat. Participants received individualized dietary plans and nutritional counseling throughout the intervention. Nutritional ketosis was monitored during the study.
Assessments were performed at baseline and after 12 weeks. Thyroid function was evaluated using serum TSH, FT3, and FT4 concentrations. Glucose-insulin metabolism was assessed using fasting glucose, fasting insulin, HbA1c, and HOMA-IR. Body mass and anthropometric measurements were also obtained to evaluate changes in adiposity-related parameters.
A total of 150 women were screened for eligibility, 120 entered the intervention, and 100 completed the 12-week study. The study was conducted at the Jerzy Kukuczka Academy of Physical Education in Katowice, Poland. The primary objective was to determine whether the metabolic and thyroid responses to a ketogenic diet differed according to baseline adiposity.
- Being tested
- Ketogenic diet
- Keywords
- Ketogenic diet, Thyroid hormones, Glucose metabolism, Overweight, Premenopausal women
- Medical subject headings
- Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietBehavioural
Participants will follow an individualized low-carbohydrate ketogenic diet for 12 weeks. The diet will provide approximately 8-10% of total energy from carbohydrates, 65-75% from fat, and 20-25% from protein. Individual energy requirements will be estimated and dietary plans will be adjusted accordingly. Participants will receive nutritional counseling and individualized meal plans to support adherence to the prescribed diet. Nutritional ketosis will be monitored throughout the intervention by measuring blood β-hydroxybutyrate (BHB) concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet Intervention | Experimental | Participants in this arm followed an individualized ketogenic diet for 12 weeks. The dietary intervention was characterized by very low carbohydrate intake, moderate protein intake, and a high proportion of dietary fat, with the aim of inducing and maintaining nutritional ketosis. Participants received individualized dietary plans and nutritional counseling throughout the intervention. Adherence to the ketogenic diet and the development of nutritional ketosis were monitored during the study. Assessments were performed at baseline and after 12 weeks. Receives: Behavioral: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Thyroid-Stimulating Hormone (TSH)
Serum thyroid-stimulating hormone (TSH) concentration will be assessed to evaluate changes in thyroid function following the 12-week ketogenic diet intervention.Unit- µIU/mL
Measured: Baseline and 12 week
Change in Fasting Insulin
Fasting serum insulin concentration will be assessed to evaluate changes in insulin metabolism following the 12-week ketogenic diet intervention.
Unit: µIU/mL
Measured: Baseline and 12 weeks
Change in Fasting Glucose
Fasting blood glucose concentration will be assessed at baseline and after the 12-week ketogenic diet intervention to evaluate changes in glucose metabolism.
Unit: mg/dL
Measured: Baseline and 12 weeks
Change in Free Thyroxine (FT4)
Serum free thyroxine (FT4) concentration will be assessed to evaluate thyroid hormone responses to the 12-week ketogenic diet intervention.Unit: ng/dL
Measured: Baseline and 12 weeks
Change in Free Triiodothyronine (FT3)
Serum free triiodothyronine (FT3) concentration will be assessed to evaluate thyroid hormone responses to the 12-week ketogenic diet intervention.Unit: pg/mL
Measured: Baseline and 12 weeks
Secondary outcomes (6)
Change in Glycated Hemoglobin (HbA1c)
HbA1c will be assessed to evaluate changes in glycemic control following the 12-week ketogenic diet intervention.
Unit: %
Measured: Baseline and 12 weeks
Change in HOMA-IR
Insulin resistance will be estimated using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations.
Unit: dimensionless index
Measured: Baseline and 12 weeks
Change in Beta-Hydroxybutyrate (BHB)
Blood beta-hydroxybutyrate (BHB) concentration will be assessed as a biochemical marker of ketogenic exposure and to confirm nutritional ketosis.
Unit: mmol/L
Measured: Baseline and 12 weeks
Change in Hip Circumference
Hip circumference will be measured using a non-elastic anthropometric measuring tape at the maximal circumference over the hip and buttock region. Changes from baseline to the end of the 12-week ketogenic diet intervention will be evaluated.
Unit: cm
Measured: Baseline and 12 weeks
Change in Thigh Circumference
Thigh circumference will be measured using a non-elastic anthropometric measuring tape at a standardized anatomical site on the thigh. The same measurement site will be used at baseline and after the intervention. Changes from baseline to the end of the 12-week ketogenic diet intervention will be evaluated.
Unit: cm
Measured: Baseline and 12 weeks
Change in Body Mass Index (BMI)
Body mass index (BMI) will be calculated as body mass in kilograms divided by height in meters squared (kg/m²). Body mass will be measured under standardized fasting conditions using the InBody 220 analyzer, and height will be measured using standard anthropometric procedures. Changes in BMI from baseline to the end of the 12-week ketogenic diet intervention will be evaluated.
Unit: kg/m²
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start3 Mar 2025
- Primary completion16 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants followed the same 12-week ketogenic diet intervention. The study used a single-group assignment model with assessments performed at baseline and after 12 weeks. For analytical purposes, participants were stratified according to baseline BMI into normal-weight, overweight, and obesity categories. These BMI categories represented analytical subgroups and not separate intervention arms.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata M Michalczyk, Proffesor, Principal investigator, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775326
- Sponsor's protocol ID
- 2/2021
- Acronym
- KETO-THYROID
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-Week Ketogenic Diet on Thyroid Function and Glucose-Insulin Metabolism in Premenopausal Women Across Different Adiposity Categories
- ClinicalTrials.gov ID
- NCT07775326
- Acronym / sponsor ID
- KETO-THYROID / 2/2021
- Keywords
- Ketogenic diet, Thyroid hormones, Glucose metabolism, Overweight, Premenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective 12-week dietary intervention study evaluated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years across different adiposity categories. Participants followed an individualized low-carbohydrate ketogenic diet designed to induce and maintain nutritional ketosis. Thyroid-related outcomes included thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4). Glucose-insulin metabolism was assessed using fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), and the homeostatic model assessment of insulin resistance (HOMA-IR). Changes in body mass and anthropometric parameters were also evaluated. Outcomes were assessed before and after the 12-week intervention and compared according to baseline BMI categories.
Detailed description
This prospective, single-group, 12-week dietary intervention study investigated the effects of a ketogenic diet on thyroid function and glucose-insulin metabolism in premenopausal women aged 30-50 years. Participants were classified according to baseline BMI into normal-weight, overweight, and obesity categories for analytical purposes. All participants received the same ketogenic dietary intervention; BMI categories did not represent separate intervention arms.
The ketogenic diet was individually prescribed and characterized by very low carbohydrate intake, moderate protein intake, and a high proportion of dietary fat. Participants received individualized dietary plans and nutritional counseling throughout the intervention. Nutritional ketosis was monitored during the study.
Assessments were performed at baseline and after 12 weeks. Thyroid function was evaluated using serum TSH, FT3, and FT4 concentrations. Glucose-insulin metabolism was assessed using fasting glucose, fasting insulin, HbA1c, and HOMA-IR. Body mass and anthropometric measurements were also obtained to evaluate changes in adiposity-related parameters.
A total of 150 women were screened for eligibility, 120 entered the intervention, and 100 completed the 12-week study. The study was conducted at the Jerzy Kukuczka Academy of Physical Education in Katowice, Poland. The primary objective was to determine whether the metabolic and thyroid responses to a ketogenic diet differed according to baseline adiposity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants followed the same 12-week ketogenic diet intervention. The study used a single-group assignment model with assessments performed at baseline and after 12 weeks. For analytical purposes, participants were stratified according to baseline BMI into normal-weight, overweight, and obesity categories. These BMI categories represented analytical subgroups and not separate intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Intervention | Experimental | Behavioral: Ketogenic dietParticipants in this arm followed an individualized ketogenic diet for 12 weeks. The dietary intervention was characterized by very low carbohydrate intake, moderate protein intake, and a high proportion of dietary fat, with the aim of inducing and maintaining nutritional ketosis. Participants received individualized dietary plans and nutritional counseling throughout the intervention. Adherence to the ketogenic diet and the development of nutritional ketosis were monitored during the study. Assessments were performed at baseline and after 12 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal status
- No use of a specific diet, calorie-restricted diet, or food-elimination regimen during the preceding 12 months
- Willingness to follow the prescribed ketogenic diet for 12 weeks
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Postmenopausal status
- Pregnancy or breastfeeding
- Previously diagnosed thyroid disease
- Thyroid hormone replacement therapy
- Use of antithyroid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietParticipants will follow an individualized low-carbohydrate ketogenic diet for 12 weeks. The diet will provide approximately 8-10% of total energy from carbohydrates, 65-75% from fat, and 20-25% from protein. Individual energy requirements will be estimated and dietary plans will be adjusted accordingly. Participants will receive nutritional counseling and individualized meal plans to support adherence to the prescribed diet. Nutritional ketosis will be monitored throughout the intervention by measuring blood β-hydroxybutyrate (BHB) concentrations. | Behavioural | Ketogenic Diet Intervention |
Primary outcome
Change in Thyroid-Stimulating Hormone (TSH)
Time frame: Baseline and 12 week
Serum thyroid-stimulating hormone (TSH) concentration will be assessed to evaluate changes in thyroid function following the 12-week ketogenic diet intervention.Unit- µIU/mL
Change in Fasting Insulin
Time frame: Baseline and 12 weeks
Fasting serum insulin concentration will be assessed to evaluate changes in insulin metabolism following the 12-week ketogenic diet intervention. Unit: µIU/mL
Change in Fasting Glucose
Time frame: Baseline and 12 weeks
Fasting blood glucose concentration will be assessed at baseline and after the 12-week ketogenic diet intervention to evaluate changes in glucose metabolism. Unit: mg/dL
Change in Free Thyroxine (FT4)
Time frame: Baseline and 12 weeks
Serum free thyroxine (FT4) concentration will be assessed to evaluate thyroid hormone responses to the 12-week ketogenic diet intervention.Unit: ng/dL
Change in Free Triiodothyronine (FT3)
Time frame: Baseline and 12 weeks
Serum free triiodothyronine (FT3) concentration will be assessed to evaluate thyroid hormone responses to the 12-week ketogenic diet intervention.Unit: pg/mL
6 secondary outcomes
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Change in HOMA-IR
Time frame: Baseline and 12 weeks
Change in Beta-Hydroxybutyrate (BHB)
Time frame: Baseline and 12 weeks
Change in Hip Circumference
Time frame: Baseline and 12 weeks
Change in Thigh Circumference
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata M Michalczyk, Proffesor principal investigator
Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Ketogenic Diet and Thyroid Function, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Thyroid-Stimulating Hormone (TSH) (time frame: Baseline and 12 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.