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Endogenous vs. Exogenous Ketone Bodies

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ClinicalTrials.gov Identifier: NCT04490226
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel

Brief Summary:

Aim of the study is to compare the origin of ketone bodies: endogenous ketone bodies due to 36 hours fasting or 24 hours of ketogenic diet vs. exogenous ketone bodies as supplements additional to normal diet.

Secondary aim of the study is to validate the new metabolic chambers.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Beta-Hydroxybutyrate as Ca-Mg-salt, active Dietary Supplement: ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active Dietary Supplement: fasting, active Dietary Supplement: fasting, inactive Not Applicable

Detailed Description:

Each study week starts with a 3-day run-in period with controlled diet at home and ends with a test-meal (breakfast) in the lab and following food record over the rest of the day at home.

  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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: all subjects are undergoing each intervention
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: fasting, active
36 hours fasting, PAL 1.6
Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.


Experimental: ketogenic diet, active
24 hours of ketogenic diet (liquid meals), PAL 1.6
Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.


Experimental: 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
Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.


Experimental: fasting, inactive
36 hours fasting, PAL 1.3
Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.

Dietary Supplement: 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.





Primary Outcome Measures :
  1. appetite control - ghrelin [ Time Frame: 24 hours ]
    ghrelin concentration in plasma (24 hour AUC)

  2. appetite control - GLP-1 concentration in plasma [ Time Frame: 24 hours ]
    Glucose Like Peptide-1 concentration in plasma (24 hour AUC)

  3. appetite control - PYY concentration in plasma [ Time Frame: 24 hours ]
    Peptide YY concentration in plasma (24 hour AUC)

  4. appetite control - subjective feelings of hunger [ Time Frame: 24 hours ]
    measured with visual analogue scales (24 hour AUC). The scale consists of a 10 cm vertical line anchored with "not hungry at all" at the left side and with "extremely hungry" at the right side.

  5. appetite control - satiety quotient [ Time Frame: 30 min ]
    satiety quotient of standard test-breakfast after 24 hours of intervention


Secondary Outcome Measures :
  1. macronutrient oxidation [ Time Frame: 24 hours ]
    measured with indirect calorimetry in a metabolic chamber

  2. energy expenditure [ Time Frame: 24 hours ]
    measured with indirect calorimetry in a metabolic chamber

  3. glycemia - glucose AUC [ Time Frame: 24 hours ]
    glucose AUC from continuous glucose monitoring data

  4. repeatability of energy expenditure measurements [ Time Frame: 24 hours ]
    repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days

  5. ß-Hydroxybutyrate concentration in serum [ Time Frame: 24 hours ]
    24 hour ß-Hydroxybutyrate concentration in serum (AUC)



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy
  • BMI 19-29 kg/m2
  • low-medium habitual physical activity
  • women using hormonal contraceptive

Exclusion Criteria:

  • smoking
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490226


Contacts
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Contact: Anja Bosy-Westphal, PhD, MD +494318805674 abosyw@nutrition.uni-kiel.de

Locations
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Germany
Institute of Human Nutrition Recruiting
Kiel, Germany, 24105
Contact: Anja Bosy-Westphal, PhD, MD    +494318805674    abosyw@nutrition.uni-kiel.de   
Sponsors and Collaborators
University of Kiel
Investigators
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Principal Investigator: Anja Bosy-Westphal, PhD, MD Institute of Human Nutrition, Kiel University
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Responsible Party: Prof. Dr. Dr. Anja Bosy-Westphal, Prof. Anja Bosy-Westphal, PhD, MD, University of Kiel
ClinicalTrials.gov Identifier: NCT04490226    
Other Study ID Numbers: ABW-2020-VK
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel:
ketone bodies
appetite control
macronutrient oxidation
metabolic chamber
exogenous ketones