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

NCT03338452 | Completed

• 1 other identifier: LEKD2017
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

ketogenic diet; body composition; metabolism; body dissatisfaction; cognition

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• Change in resting energy rate

  Resting energy rate will be determined with indirect calorimetry.

  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.

  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).

  Change from baseline to 12 weeks.

• Change in psychological factors

  Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).

  Change from baseline to 12 weeks.

Secondary Outcomes (2)

• Change in body weight following intervention

  Change from 12 weeks to 12 months.

• Adherence to ketogenic diet

  At 12 months.

Study Arms (1)

participants

EXPERIMENTAL

The participants will be subjected to low energy ketogenic diet.

Behavioral: Low energy ketogenic diet

Interventions

Low energy ketogenic diet BEHAVIORAL

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.

participants

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

Location

Related 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.

  PMID: 28053201 BACKGROUND

• 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.

  PMID: 956398 BACKGROUND

• 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.

  PMID: 28239404 BACKGROUND

• 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.

  PMID: 25101284 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zala Jenko Pražnikar, PhD

  University of Primorska, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. prof. dr. sc.

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 9, 2017
• Study Start: March 18, 2017
• Primary Completion: June 17, 2017
• Study Completion: June 24, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

SL (1)