Clinical Trials Directory

Trials / Completed

CompletedNCT04490226

Endogenous vs. Exogenous Ketone Bodies

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
University of Kiel · Academic / Other
Sex
All
Age
20 Years – 35 Years
Healthy volunteers
Accepted

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)

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBeta-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_SUPPLEMENTketogenic 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_SUPPLEMENTfasting, 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_SUPPLEMENTfasting, 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.

Timeline

Start date
2020-08-21
Primary completion
2021-07-23
Completion
2021-07-23
First posted
2020-07-29
Last updated
2021-10-01

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04490226. Inclusion in this directory is not an endorsement.