Skip to content

Endogenous vs. Exogenous Ketone Bodies

Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04490226
Enrollment
8
Registered
2020-07-29
Start date
2020-08-21
Completion date
2021-07-23
Last updated
2021-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ketone bodies, appetite control, macronutrient oxidation, metabolic chamber, exogenous ketones

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.

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)

Interventions

DIETARY_SUPPLEMENTBeta-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_SUPPLEMENTketogenic 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_SUPPLEMENTfasting, 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_SUPPLEMENTfasting, 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.

Sponsors

University of Kiel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

all subjects are undergoing each intervention

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
appetite control - satiety quotient30 minsatiety quotient of standard test-breakfast after 24 hours of intervention
appetite control - ghrelin24 hoursghrelin concentration in plasma (24 hour AUC)
appetite control - GLP-1 concentration in plasma24 hoursGlucose Like Peptide-1 concentration in plasma (24 hour AUC)
appetite control - PYY concentration in plasma24 hoursPeptide YY concentration in plasma (24 hour AUC)
appetite control - subjective feelings of hunger24 hoursmeasured 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.

Secondary

MeasureTime frameDescription
macronutrient oxidation24 hoursmeasured with indirect calorimetry in a metabolic chamber
energy expenditure24 hoursmeasured with indirect calorimetry in a metabolic chamber
glycemia - glucose AUC24 hoursglucose AUC from continuous glucose monitoring data
repeatability of energy expenditure measurements24 hoursrepeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days
ß-Hydroxybutyrate concentration in serum24 hours24 hour ß-Hydroxybutyrate concentration in serum (AUC)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026