Low Energy Ketogenic Diet in Obese Subjects - the Impact on Whole Organism
NCT ID: NCT03338452
Last Updated: 2018-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2017-03-18
2018-06-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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participants
The participants will be subjected to low energy ketogenic diet.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* asymptomatic for any disease except obesity
Exclusion Criteria
* 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.
25 Years
55 Years
ALL
No
Sponsors
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University of Primorska
OTHER
Responsible Party
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Zala Jenko Praznikar
Assist. prof. dr. sc.
Principal Investigators
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Zala Jenko Pražnikar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Primorska, Faculty of Health Sciences
Locations
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University of Primorska, Faculty of Health Sciences
Izola, , Slovenia
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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LEKD2017
Identifier Type: -
Identifier Source: org_study_id
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