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Completed

NCT Number: NCT07775326

Dietary Macronutrients and Metabolic Markers

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.

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice

Katowice, 40-065, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Premenopausal status, defined by ongoing menstrual cycles and no history of menopause.

No use of a specific diet, calorie-restricted diet, or food-elimination regimen during the preceding 12 months.

Low-to-moderate habitual physical activity. Willingness to follow the prescribed ketogenic diet for 12 weeks. Willingness to participate in all study assessments. Provision of written informed consent.

Exclusion criteria

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.

Use of dietary supplements known to substantially affect glucose or lipid metabolism before enrollment.

Pharmacological treatment for insulin resistance. Pharmacological treatment for dyslipidemia.

Treatment and study plan

Ketogenic diet

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    HbA1c will be assessed to evaluate changes in glycemic control following the 12-week ketogenic diet intervention.

    Unit: %

  2. Change in HOMA-IR

    Time frame: Baseline and 12 weeks

    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

  3. Change in Beta-Hydroxybutyrate (BHB)

    Time frame: Baseline and 12 weeks

    Blood beta-hydroxybutyrate (BHB) concentration will be assessed as a biochemical marker of ketogenic exposure and to confirm nutritional ketosis.

    Unit: mmol/L

  4. Change in Hip Circumference

    Time frame: Baseline and 12 weeks

    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

  5. Change in Thigh Circumference

    Time frame: Baseline and 12 weeks

    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

  6. Change in Body Mass Index (BMI)

    Time frame: Baseline and 12 weeks

    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

Sponsors and collaborators

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice

Other

Registry information

Official study title

Effects of a 12-Week Ketogenic Diet on Thyroid Function and Glucose-Insulin Metabolism in Premenopausal Women Across Different Adiposity Categories

Acronym: KETO-THYROID

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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