Low Energy Ketogenic Diet in Obese Subjects - the Impact on Whole Organism (KETO)

University of Primorska

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Low energy ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03338452

LEKD2017

Details and patient eligibility

About

The study evaluates the timeline of changes of body composition, physical and psychological performance, and biochemical markers of metabolism and inflammation responses to low energy ketogenic diet for loosing weight in obese individuals. The participants will be monitored and guided by the interdisciplinary obesity team for 12 weeks.

Full description

Ketogenic diets have been shown to be an effective tool to fight obesity with reported good adherence due to their ability to suppress the drive to eat. They are also gaining popularity in public, despite some concerns regarding the quality and timeline of changes of body composition and the effects on health parameters of whole organism.

For effective weight loss, energy deficit is required. Very low energy (600 - 800 kcal) ketogenic diets have been extensively studied.

The proposed study combines low energy (800 - 1500 kcal) and ketogenic diet intervention. The aim of the study is a comprehensive determination of quality of body mass loss, metabolic states changes, physical and psychological performance changes, and inflammatory and hormones profile changes during and post a 12-week low energy ketogenic diet intervention.

Enrollment: 38 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI > 30 kg/m2
• asymptomatic for any disease except obesity

Exclusion criteria

• presence of cardiovascular, endocrine, acute or chronic inflammatory diseases;
• taking medications for lipid metabolism, or psychiatric disorders;
• adherence to a prescribed diet;
• unstable weight in the past 3 months;
• BMI < 30 kg/m2;
• unwilling or unable to eat the foods prescribed in the study;
• vigorous physical activity;
• pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

participants

Experimental group

Description:

The participants will be subjected to low energy ketogenic diet.

Treatment:

Behavioral: Low energy ketogenic diet