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
8 participants
INTERVENTIONAL
2020-08-21
2021-07-23
Brief Summary
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Secondary aim of the study is to validate the new metabolic chambers.
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Detailed Description
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1. week: physical activity level (PAL) 1.3, 3 intervention days in the metabolic chamber: ad libitum energy intake, washout day, isocaloric diet, 36 hours fasting
2. week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting
3. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting
4. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric)
5. week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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fasting, active
36 hours fasting, PAL 1.6
Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
exogeneous ketone bodies, active
24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6
Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
fasting, inactive
36 hours fasting, PAL 1.3
Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
Interventions
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Beta-Hydroxybutyrate as Ca-Mg-salt, active
24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active
24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, active
36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
fasting, inactive
36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
The same intervention is reproduced one week later.
Eligibility Criteria
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Inclusion Criteria
* BMI 19-29 kg/m2
* low-medium habitual physical activity
* women using hormonal contraceptive
Exclusion Criteria
* chronic illnesses
* food allergies / intolerances
* vegans and vegetarians
* regular high physical activity (exercise \>1 hour/d)
* current weight loss diet / weight loss of \>5 kg in the last 3 months
* pregnant / lactating women
* persons incapable of giving informed legal consent
20 Years
35 Years
ALL
Yes
Sponsors
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University of Kiel
OTHER
Responsible Party
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Prof. Dr. Dr. Anja Bosy-Westphal
Prof. Anja Bosy-Westphal, PhD, MD
Principal Investigators
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Anja Bosy-Westphal, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Human Nutrition, Kiel University
Locations
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Institute of Human Nutrition
Kiel, , Germany
Countries
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References
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Hagele FA, Dorner R, Koop J, Lubken M, Seidel U, Rimbach G, Muller MJ, Bosy-Westphal A. Impact of one-day fasting, ketogenic diet or exogenous ketones on control of energy balance in healthy participants. Clin Nutr ESPEN. 2023 Jun;55:292-299. doi: 10.1016/j.clnesp.2023.03.025. Epub 2023 Apr 10.
Dorner R, Hagele FA, Koop J, Rising R, Foerster T, Olsen T, Hasler M, Muller MJ, Bosy-Westphal A. Validation of energy expenditure and macronutrient oxidation measured by two new whole-room indirect calorimeters. Obesity (Silver Spring). 2022 Sep;30(9):1796-1805. doi: 10.1002/oby.23527. Epub 2022 Aug 4.
Other Identifiers
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ABW-2020-VK
Identifier Type: -
Identifier Source: org_study_id
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