Endogenous vs. Exogenous Ketone Bodies

NCT04490226 | Completed

• 1 other identifier: ABW-2020-VK
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (5)

• appetite control - ghrelin

  ghrelin concentration in plasma (24 hour AUC)

  24 hours

• appetite control - GLP-1 concentration in plasma

  Glucose Like Peptide-1 concentration in plasma (24 hour AUC)

  24 hours

• appetite control - PYY concentration in plasma

  Peptide YY concentration in plasma (24 hour AUC)

  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.

  24 hours

• appetite control - satiety quotient

  satiety quotient of standard test-breakfast after 24 hours of intervention

  30 min

Secondary Outcomes (5)

• macronutrient oxidation

  24 hours

• energy expenditure

  24 hours

• glycemia - glucose AUC

  24 hours

• repeatability of energy expenditure measurements

  24 hours

• ß-Hydroxybutyrate concentration in serum

  24 hours

Study Arms (4)

fasting, active

EXPERIMENTAL

36 hours fasting, PAL 1.6

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

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

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

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

Interventions

Beta-Hydroxybutyrate as Ca-Mg-salt, active DIETARY_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.

exogeneous ketone bodies, active; fasting, active; fasting, inactive; ketogenic diet, active

ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active DIETARY_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.

exogeneous ketone bodies, active; fasting, active; fasting, inactive; ketogenic diet, active

fasting, active DIETARY_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.

exogeneous ketone bodies, active; fasting, active; fasting, inactive; ketogenic diet, active

fasting, inactive DIETARY_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.

exogeneous ketone bodies, active; fasting, active; fasting, inactive; ketogenic diet, active

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kiel: lead

Study Sites (1)

Institute of Human Nutrition

Kiel, 24105, Germany

Location

Related Publications (2)

• 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.

  PMID: 37202059 DERIVED

• 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.

  PMID: 35927795 DERIVED

MeSH Terms

Interventions

3-Hydroxybutyric Acid; Exercise; Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Ketone Bodies; Ketones; Fatty Acids, Volatile; Fatty Acids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anja Bosy-Westphal, PhD, MD

  Institute of Human Nutrition, Kiel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Anja Bosy-Westphal, PhD, MD

Model Details: all subjects are undergoing each intervention

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 29, 2020
• Study Start: August 21, 2020
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

DE (1)