Clinical trial NCT04490226: Endogenous vs. Exogenous Ketone Bodies
Official title: Impact of Endogenous vs. Exogenous Ketone Bodies on Appetite Control and Macronutrient Oxidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: ketone bodies
appetite control
macronutrient oxidation
metabolic chamber
exogenous ketones
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: all subjects are undergoing each intervention
Primary purpose: BASIC_SCIENCE

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)

Eligibility 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

Primary outcomes:
measure: appetite control - ghrelin
timeFrame: 24 hours
measure: appetite control - GLP-1 concentration in plasma
timeFrame: 24 hours
measure: appetite control - PYY concentration in plasma
timeFrame: 24 hours
measure: appetite control - subjective feelings of hunger
timeFrame: 24 hours
measure: appetite control - satiety quotient
timeFrame: 30 min
Secondary outcomes:
measure: macronutrient oxidation
timeFrame: 24 hours
measure: energy expenditure
timeFrame: 24 hours
measure: glycemia - glucose AUC
timeFrame: 24 hours
measure: repeatability of energy expenditure measurements
timeFrame: 24 hours
measure: ß-Hydroxybutyrate concentration in serum
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition
Study officials:
affiliation: Institute of Human Nutrition, Kiel University
name: Anja Bosy-Westphal, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.