Ketogenic Diet / Thyroid Function / Insulin Resistance · Interventional Study

Dietary Macronutrients and Metabolic Markers

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed single-arm interventional study of ketogenic diet effects on thyroid function and glucose-insulin metabolism in premenopausal women aged 30–50 years. No results are posted in this registry record, so efficacy, safety, or effect sizes cannot be assessed.

What was studied

Interventional, Single Group, Open label, Basic Science purpose. Ketogenic Diet, Thyroid Function, Insulin Resistance, Obesity Overweight; Female; age from 30 Years; to 50 Years; accepts healthy volunteers. Intervention: Ketogenic Diet Intervention. n = 120. 1 site: Poland.

Key findings

Safety

This registry record reports no results; efficacy, safety, and effect sizes are unknown.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed interventional study with 120 participants and defined metabolic endpoints, but the registry record contains no results, only study design and planned outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Change in Thyroid-Stimulating Hormone (TSH) (assessed at Baseline and 12 week); Change in Fasting Insulin (assessed at Baseline and 12 weeks); Change in Fasting Glucose (assessed at Baseline and 12 weeks); Change in Free Thyroxine (FT4) (assessed at Baseline and 12 weeks); Change in Free Triiodothyronine (FT3) (assessed at Baseline and 12 weeks)

DesignInterventional, Single Group, Open label, Basic Science purpose

PopulationKetogenic Diet, Thyroid Function, Insulin Resistance, Obesity Overweight; Female; age from 30 Years; to 50 Years; accepts healthy volunteers

Sample size120

InterventionKetogenic Diet Intervention

Setting1 site: Poland

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

Intervention duration12 weeks

Primary outcome: TSHChange from baseline to 12 weeks

Primary outcome: Fasting insulinChange from baseline to 12 weeks

Primary outcome: Fasting glucoseChange from baseline to 12 weeks

Primary outcome: FT4Change from baseline to 12 weeks

Primary outcome: FT3Change from baseline to 12 weeks

Caveats

This registry record reports no results; efficacy, safety, and effect sizes are unknown.
No control or comparator arm is described in the registry record.
Blinding, allocation concealment, and other bias mitigation methods are not stated.
Secondary outcomes (HbA1c, HOMA-IR, body mass, anthropometric parameters) are mentioned but not listed as primary outcomes in the record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective 12-week dietary intervention; no control arm described in registry record.

Directness

strong

Primary outcomes are clinically relevant metabolic markers: TSH, FT3, FT4, fasting glucose, fasting insulin.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias mitigation methods.

Sample adequacy

moderate

120 participants enrolled; sample size justification not stated in registry record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07775326). This is a study registration, not published results. Lead sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ACTUAL). Conditions: Ketogenic Diet, Thyroid Function, Insulin Resistance, Obesity Overweight. Interventions: BEHAVIORAL: Ketogenic diet. Primary outcome measures: Change in Thyroid-Stimulating Hormone (TSH) , Baseline and 12 week; Change in Fasting Insulin , Baseline and 12 weeks; Change in Fasting Glucose , Baseline and 12 weeks; Change in Free Thyroxine (FT4) , Baseline and 12 weeks; Change in Free Triiodothyronine (FT3) , Baseline and 12 weeks. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

The Jerzy Kukuczka Academy of Physical Education in KatowiceKetogenic DietThyroid FunctionInsulin ResistanceNCT07775326Ketogenic Diet