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

Obesity Clinical Trial

— KETO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338452
• Other study ID #: LEKD2017
• Status: Completed
• Phase: N/A
• Start date: March 18, 2017
• Est. completion date: June 24, 2018

Study information

• Verified date: October 2018
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The participants will be monitored and guided by the interdisciplinary obesity team for 12 weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 24, 2018
• Est. primary completion date: June 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University of Primorska, Faculty of Health Sciences	Izola

Sponsors (1)

Lead Sponsor	Collaborator
University of Primorska

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline over 12 weeks with intermediate time points at 1, 2, 4 and 8 weeks.
Primary	Change in beta-hydroxybutirate	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.
Primary	Change in resting energy rate	Resting energy rate will be determined with indirect calorimetry.	Change from baseline to 12 weeks.
Primary	Change in physical fitness	Physical fitness will be determined using 2 km walking test according to the UKK Walk Test Programme.	Change from baseline to 12 weeks.
Primary	Change in cognitive functions	Will be assessed by validated psychological test (Wechsler Adult Intelligence Scale - Forth Edition (WAIS-IV).	Change from baseline to 12 weeks.
Primary	Change in psychological factors	Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).	Change from baseline to 12 weeks.
Secondary	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).	Change from 12 weeks to 12 months.
Secondary	Adherence to ketogenic diet	Adherence to ketogenic diet will be assessed by 3-day food record.	At 12 months.