ObesityKETONCT03338452

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

A study testing Low energy ketogenic diet in people with Obesity, run by University of Primorska at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Obesity
What is being tested?: Low energy ketogenic diet
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteSlovenia
Study dates: 18 Mar 2017to 24 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Slovenia1 site

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

Other trials in Slovenia

About this study

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

Read the 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.

Conditions: Obesity
Being tested: Low energy ketogenic diet
Keywords: ketogenic diet, body composition, metabolism, body dissatisfaction, cognition
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low energy ketogenic dietBehavioural
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.

Study groups in NCT03338452
Study group	Role	What they receive
participants	Experimental	The participants will be subjected to low energy ketogenic diet. Receives: Behavioral: Low energy ketogenic diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201724 Jun 2018

First posted9 Nov 2017
Study start18 Mar 2017
Primary completion17 Jun 2017
Study completion24 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Longitudinal intervention study with repeated measurements. Participants will be subjected to a 12-week low energy ketogenic diet (LEKD) and requested not to change their physical activity levels throughout the study. The participants will underwent a series of tests and consultations at baseline (prior to the start of the intervention), and after 1, 2, 4, 8 , and 12 weeks of LEKD intervention. At the end of each time points, body weight and composition will be measured in the fasting state, food and exercise diaries checked by a dietitian and a kinesiologist and discussed with the participants, psychological and cognitive tests will be performed by a psychologist. At the same time-points, different serum analyses will be performed.
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03338452
Sponsor's protocol ID: LEKD2017
Acronym: KETO
Status last verified: Oct 2018
First submitted: 27 Oct 2017
Last updated: 12 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Noakes TD, Windt J. Evidence that supports the prescription of low-carbohydrate high-fat diets: a narrative review. Br J Sports Med. 2017 Jan;51(2):133-139. doi: 10.1136/bjsports-2016-096491.
PubMed 28053201
Yang MU, Van Itallie TB. Composition of weight lost during short-term weight reduction. Metabolic responses of obese subjects to starvation and low-calorie ketogenic and nonketogenic diets. J Clin Invest. 1976 Sep;58(3):722-30. doi: 10.1172/JCI108519.
PubMed 956398
Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.
PubMed 28239404
Paoli A, Bianco A, Damiani E, Bosco G. Ketogenic diet in neuromuscular and neurodegenerative diseases. Biomed Res Int. 2014;2014:474296. doi: 10.1155/2014/474296. Epub 2014 Jul 3.
PubMed 25101284

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Effects on Whole Organism of Low Energy Ketogenic Diet for Weight Loss in Obese Subjects
ClinicalTrials.gov ID: NCT03338452
Acronym / sponsor ID: KETO / LEKD2017
Conditions: Obesity
Keywords: ketogenic diet, body composition, metabolism, body dissatisfaction, cognition
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of PrimorskaUniversity, hospital or other
Study start: 18 Mar 2017 (actual)
Primary completion: 17 Jun 2017 (actual)
Study completion: 24 Jun 2018 (actual)
First posted: 9 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Longitudinal intervention study with repeated measurements. Participants will be subjected to a 12-week low energy ketogenic diet (LEKD) and requested not to change their physical activity levels throughout the study. The participants will underwent a series of tests and consultations at baseline (prior to the start of the intervention), and after 1, 2, 4, 8 , and 12 weeks of LEKD intervention. At the end of each time points, body weight and composition will be measured in the fasting state, food and exercise diaries checked by a dietitian and a kinesiologist and discussed with the participants, psychological and cognitive tests will be performed by a psychologist. At the same time-points, different serum analyses will be performed.

Arm	Type	Receives
participants	Experimental	Behavioral: Low energy ketogenic dietThe participants will be subjected to low energy ketogenic diet.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Low energy ketogenic dietLow 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.	Behavioural	participants

Primary outcome

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 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 in resting energy rate
Time frame: Change from baseline to 12 weeks.
Resting energy rate will be determined with indirect calorimetry.
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 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 in psychological factors
Time frame: Change from baseline to 12 weeks.
Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).

2 secondary outcomes

Change in body weight following intervention
Time frame: Change from 12 weeks to 12 months.
Adherence to ketogenic diet
Time frame: At 12 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
Background: PubMed 28053201Noakes TD, Windt J. Evidence that supports the prescription of low-carbohydrate high-fat diets: a narrative review. Br J Sports Med. 2017 Jan;51(2):133-139. doi: 10.1136/bjsports-2016-096491.
Background: PubMed 956398Yang MU, Van Itallie TB. Composition of weight lost during short-term weight reduction. Metabolic responses of obese subjects to starvation and low-calorie ketogenic and nonketogenic diets. J Clin Invest. 1976 Sep;58(3):722-30. doi: 10.1172/JCI108519.
Background: PubMed 28239404Urbain P, Strom L, Morawski L, Wehrle A, Deibert P, Bertz H. Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Nutr Metab (Lond). 2017 Feb 20;14:17. doi: 10.1186/s12986-017-0175-5. eCollection 2017.
Background: PubMed 25101284Paoli A, Bianco A, Damiani E, Bosco G. Ketogenic diet in neuromuscular and neurodegenerative diseases. Biomed Res Int. 2014;2014:474296. doi: 10.1155/2014/474296. Epub 2014 Jul 3.
Individual participant dataSharing planned: Undecided

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zala Jenko Pražnikar, PhD principal investigator

University of Primorska, Faculty of Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low energy ketogenic diet in people with Obesity, run by University of Primorska at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body composition (time frame: Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03338452, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.