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

October 11, 2018 updated by: Zala Jenko Praznikar, University of Primorska

The Safety and Effects on Whole Organism of Low Energy Ketogenic Diet for Weight Loss in Obese Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Izola, Slovenia, SI-6310
        • University of Primorska, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participants
The participants will be subjected to low energy ketogenic diet.
Behavioral: Low energy ketogenic diet
Low energy ketogenic diet lasting 12 weeks with a previous preparation period including detailed instructions during classes and individual counselling by a dietitian. Participants were provided with a list of suitable foods with very low carbohydrate content. Furthermore, the subjects shared cooking recipes and links to helpful webpages. They were free to follow a KD according to their personal preferences but limit their carbohydrate intake to 5-10 % of total energy from carbohydrates, but derive at least 70 % of total energy from fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body composition
Time Frame: Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Body mass, fat free body mass and fat mass will be measured (all in kilograms) with bioelectrical impedance analysis (BIA) Tanita BC 418MA.
Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Change in beta-hydroxybutirate
Time Frame: Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Overnight fasted serum beta-hydroxybutirate will be determined (in mmol/l).
Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Change in resting energy rate
Time Frame: Change from baseline to 12 weeks.
Resting energy rate will be determined with indirect calorimetry.
Change from baseline to 12 weeks.
Change in physical fitness
Time Frame: Change from baseline to 12 weeks.
Physical fitness will be determined using 2 km walking test according to the UKK Walk Test Programme.
Change from baseline to 12 weeks.
Change in cognitive functions
Time Frame: Change from baseline to 12 weeks.
Will be assessed by validated psychological test (Wechsler Adult Intelligence Scale - Forth Edition (WAIS-IV).
Change from baseline to 12 weeks.
Change in psychological factors
Time Frame: Change from baseline to 12 weeks.
Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).
Change from baseline to 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight following intervention
Time Frame: Change from 12 weeks to 12 months.
Maintenance of body mass at the end of intervention will be evaluated over the 12 months following intervention (in kilogrames).
Change from 12 weeks to 12 months.
Adherence to ketogenic diet
Time Frame: At 12 months.
Adherence to ketogenic diet will be assessed by 3-day food record.
At 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Investigators

  • Principal Investigator: Zala Jenko Pražnikar, PhD, University of Primorska, Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2017

Primary Completion (Actual)

June 17, 2017

Study Completion (Actual)

June 24, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LEKD2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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