Low Energy Ketogenic Diet in Obese Subjects - the Impact on Whole Organism
- Conditions
- Obesity
- Interventions
- Behavioral: Low energy ketogenic diet
- Registration Number
- NCT03338452
- Lead Sponsor
- University of Primorska
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- BMI > 30 kg/m2
- asymptomatic for any disease except obesity
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description participants Low energy ketogenic diet The participants will be subjected to low energy ketogenic diet.
- Primary Outcome Measures
Name Time Method Change in body composition 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 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 Change from baseline to 12 weeks. Resting energy rate will be determined with indirect calorimetry.
Change in physical fitness 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 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 Change from baseline to 12 weeks. Will be assessed by validated psychological test (Dutch Eating Behavior Questionnaire (DEBQ).
- Secondary Outcome Measures
Name Time Method Change in body weight following intervention 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).
Adherence to ketogenic diet At 12 months. Adherence to ketogenic diet will be assessed by 3-day food record.
Trial Locations
- Locations (1)
University of Primorska, Faculty of Health Sciences
🇸🇮Izola, Slovenia