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Completed

NCT Number: NCT04490226

Endogenous vs. Exogenous Ketone Bodies

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.

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Human Nutrition

Kiel, 24105, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. appetite control - ghrelin

    Time frame: 24 hours

    ghrelin concentration in plasma (24 hour AUC)

  2. appetite control - GLP-1 concentration in plasma

    Time frame: 24 hours

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

  3. appetite control - PYY concentration in plasma

    Time frame: 24 hours

    Peptide YY concentration in plasma (24 hour AUC)

  4. 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.

  5. appetite control - satiety quotient

    Time frame: 30 min

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

Secondary outcomes

  1. macronutrient oxidation

    Time frame: 24 hours

    measured with indirect calorimetry in a metabolic chamber

  2. energy expenditure

    Time frame: 24 hours

    measured with indirect calorimetry in a metabolic chamber

  3. glycemia - glucose AUC

    Time frame: 24 hours

    glucose AUC from continuous glucose monitoring data

  4. repeatability of energy expenditure measurements

    Time frame: 24 hours

    repeated measurement of 24h-energy expenditure in a metabolic chamber on inactive isocaloric and fasting days

  5. ß-Hydroxybutyrate concentration in serum

    Time frame: 24 hours

    24 hour ß-Hydroxybutyrate concentration in serum (AUC)

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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