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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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.
University of Primorska, Faculty of Health Sciences
Izola, Slovenia
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Change from baseline to 12 weeks.
Change in psychological factors
Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).
Time frame: Change from baseline to 12 weeks.
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).
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Time frame: Change from 12 weeks to 12 months.
Adherence to ketogenic diet
Adherence to ketogenic diet will be assessed by 3-day food record.
Time frame: At 12 months.