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Completed

NCT Number: NCT03338452

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

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.

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Key information

Conditions

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

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, SI-6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. Change in resting energy rate

    Time frame: Change from baseline to 12 weeks.

    Resting energy rate will be determined with indirect calorimetry.

  4. 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.

  5. 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).

  6. Change in psychological factors

    Time frame: Change from baseline to 12 weeks.

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

Secondary outcomes

  1. Change in body weight following intervention

    Time frame: 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).

  2. Adherence to ketogenic diet

    Time frame: At 12 months.

    Adherence to ketogenic diet will be assessed by 3-day food record.

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

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

Acronym: KETO

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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