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Outcome Measures

Primary Outcomes (5)

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
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
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
Baseline and 12 weeks

Study Arms (1)

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.

Behavioral: Ketogenic diet

Interventions

Ketogenic dietBehavioral

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.

Ketogenic Diet Intervention

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MeSH Terms

Conditions

Insulin ResistanceOverweight

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

BASIC SCIENCE

Intervention Model

SINGLE GROUP

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Dietary Macronutrients and Metabolic Markers

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Primary Completion

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Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

Ketogenic Diet Intervention

Interventions

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Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

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Study Record Dates

Secondary Outcomes (6)

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (1)

Ketogenic Diet Intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (6)

You may not qualify if:

Data Sharing

Source record

Locations