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Dietary Macronutrients and Metabolic Markers

NCT07775326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • The Jerzy Kukuczka Academy of Physical Education in Katowice

    lead OTHER

Principal Investigators

  • Małgorzata M Michalczyk, Proffesor · Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2025-12-16
Completion
2025-12-19

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775326 on ClinicalTrials.gov