Endogenous vs. Exogenous Ketone Bodies

University of Kiel

Status: Completed

Conditions: Healthy

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04490226

ABW-2020-VK

Details and patient eligibility

About

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.

Full 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)

Enrollment: 8 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

fasting, active

Experimental group

Description:

36 hours fasting, PAL 1.6

Treatment:

Dietary Supplement: fasting, inactive

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

ketogenic diet, active

Experimental group

Description:

24 hours of ketogenic diet (liquid meals), PAL 1.6

Treatment:

Dietary Supplement: fasting, inactive

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

exogeneous ketone bodies, active

Experimental group

Description:

24 hours of ketone body supplements (Beta-Hydroxybutyrate as Ca-Mg-salt) additional to a normal diet (liquid meals), PAL 1.6

Treatment:

Dietary Supplement: fasting, inactive

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

fasting, inactive

Experimental group

Description:

36 hours fasting, PAL 1.3

Treatment:

Dietary Supplement: fasting, inactive

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