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COMPLETED
NCT07775326
NA

Dietary Macronutrients and Metabolic Markers

Sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

30 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-03-03

Completion Date

2025-12-19

Last Updated

2026-08-20

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Ketogenic diet

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.

Locations (1)

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

Katowice, Poland