HealthyNCT04490226
Endogenous vs. Exogenous Ketone Bodies
A study testing Beta-Hydroxybutyrate as Ca-Mg-salt, active, ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active and fasting, active in people with Healthy, run by University of Kiel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beta-Hydroxybutyrate as Ca-Mg-salt, active, ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active and fasting, active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 21 Aug 2020to 23 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI 19-29 kg/m2
- low-medium habitual physical activity
- women using hormonal contraceptive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation
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.
Read the 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.
- 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
- week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric)
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)
- Conditions
- Healthy
- Being tested
- Beta-Hydroxybutyrate as Ca-Mg-salt, active, ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active, fasting, active, fasting, inactive
- Keywords
- ketone bodies, appetite control, macronutrient oxidation, metabolic chamber, exogenous ketones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Hydroxybutyrate as Ca-Mg-salt, activeDietary supplement
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), activeDietary supplement
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, activeDietary supplement
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, inactiveDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| fasting, active | Experimental | 36 hours fasting, PAL 1.6 Receives: 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 |
| ketogenic diet, active | Experimental | 24 hours of ketogenic diet (liquid meals), PAL 1.6 Receives: 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 |
| exogeneous ketone bodies, active | Experimental | 24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6 Receives: 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 |
| fasting, inactive | Experimental | 36 hours fasting, PAL 1.3 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite control - ghrelin
ghrelin concentration in plasma (24 hour AUC)
Measured: 24 hours
appetite control - GLP-1 concentration in plasma
Glucose Like Peptide-1 concentration in plasma (24 hour AUC)
Measured: 24 hours
appetite control - PYY concentration in plasma
Peptide YY concentration in plasma (24 hour AUC)
Measured: 24 hours
appetite control - subjective feelings of hunger
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.
Measured: 24 hours
appetite control - satiety quotient
satiety quotient of standard test-breakfast after 24 hours of intervention
Measured: 30 min
Secondary outcomes (5)
macronutrient oxidation
measured with indirect calorimetry in a metabolic chamber
Measured: 24 hours
energy expenditure
measured with indirect calorimetry in a metabolic chamber
Measured: 24 hours
glycemia - glucose AUC
glucose AUC from continuous glucose monitoring data
Measured: 24 hours
repeatability of energy expenditure measurements
repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days
Measured: 24 hours
ß-Hydroxybutyrate concentration in serum
24 hour ß-Hydroxybutyrate concentration in serum (AUC)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start21 Aug 2020
- Primary completion23 Jul 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- all subjects are undergoing each intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Anja Bosy-Westphal, University of Kiel
- Investigators
- Anja Bosy-Westphal, PhD, MD, Principal investigator, Institute of Human Nutrition, Kiel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490226
- Sponsor's protocol ID
- ABW-2020-VK
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37202059Dorner 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.
PubMed 35927795
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation
- ClinicalTrials.gov ID
- NCT04490226
- Acronym / sponsor ID
- ABW-2020-VK
- Conditions
- Healthy
- Keywords
- ketone bodies, appetite control, macronutrient oxidation, metabolic chamber, exogenous ketones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 23 Jul 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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
- week: physical activity level (PAL) 1.3, 2 intervention days in the metabolic chamber: isocaloric diet, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: ad libitum energy intake, 36 hours fasting
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, ketogenic diet (isocaloric)
- week: physical activity level (PAL) 1.6, 2 intervention days in the metabolic chamber: isocaloric diet, isocaloric diet + ketone body supplements (isocaloric)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- all subjects are undergoing each intervention
| Arm | Type | Receives |
|---|---|---|
| fasting, active | Experimental | 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, inactive36 hours fasting, PAL 1.6 |
| ketogenic diet, active | Experimental | 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, inactive24 hours of ketogenic diet (liquid meals), PAL 1.6 |
| exogeneous ketone bodies, active | Experimental | 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, inactive24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6 |
| fasting, inactive | Experimental | 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, inactive36 hours fasting, PAL 1.3 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- BMI 19-29 kg/m2
- low-medium habitual physical activity
- women using hormonal contraceptive
Key exclusion criteria (8 listed)
- smoking
- chronic illnesses
- food allergies / intolerances
- vegans and vegetarians
- regular high physical activity (exercise >1 hour/d)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-Hydroxybutyrate as Ca-Mg-salt, active24 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 | exogeneous ketone bodies, active, fasting, active, fasting, inactive, ketogenic diet, active |
| ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active24 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 | exogeneous ketone bodies, active, fasting, active, fasting, inactive, ketogenic diet, active |
| fasting, active36 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 | exogeneous ketone bodies, active, fasting, active, fasting, inactive, ketogenic diet, active |
| fasting, inactive36 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. | Dietary supplement | exogeneous ketone bodies, active, fasting, active, fasting, inactive, ketogenic diet, active |
Primary outcome
appetite control - ghrelin
Time frame: 24 hours
ghrelin concentration in plasma (24 hour AUC)
appetite control - GLP-1 concentration in plasma
Time frame: 24 hours
Glucose Like Peptide-1 concentration in plasma (24 hour AUC)
appetite control - PYY concentration in plasma
Time frame: 24 hours
Peptide YY concentration in plasma (24 hour AUC)
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.
appetite control - satiety quotient
Time frame: 30 min
satiety quotient of standard test-breakfast after 24 hours of intervention
5 secondary outcomes
macronutrient oxidation
Time frame: 24 hours
energy expenditure
Time frame: 24 hours
glycemia - glucose AUC
Time frame: 24 hours
repeatability of energy expenditure measurements
Time frame: 24 hours
ß-Hydroxybutyrate concentration in serum
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 37202059Hagele 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.
- Derived from this study: PubMed 35927795Dorner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Bosy-Westphal, PhD, MD principal investigator
Institute of Human Nutrition, Kiel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Hydroxybutyrate as Ca-Mg-salt, active, ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active and fasting, active in people with Healthy, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appetite control - ghrelin (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.