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How Orally Consumed 3-hydroxybuturate Alters Metabolism

Primary Purpose

Acute Ketosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3-hydroxybuturate
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Ketosis

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 20-30

Exclusion Criteria:

  • Smoking
  • alcohol or drug abuse
  • Critically ill

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Subjects drink 3-hydroxybuturate

Subjects drink saline

Outcomes

Primary Outcome Measures

3-hydroxybuturate
blood level of 3-hydroxybuturate

Secondary Outcome Measures

Glucose
Glucose tracer kinetics, endogenous glucose production, muscle biopsy
lipid metabolism
Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies

Full Information

First Posted
September 27, 2016
Last Updated
April 7, 2017
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02917252
Brief Title
How Orally Consumed 3-hydroxybuturate Alters Metabolism
Official Title
Ketone Bodies Ingested Orally Alter Metabolism for Glucose, Lipid, and Protein
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
April 3, 2017 (Actual)
Study Completion Date
April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.
Detailed Description
Subject participate for two separate days; i) intervention, ii) placebo. Intervention: subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is applied. Muscle tissue and adipose tissue biopsies are taken. Placebo: subjects drink saline. Same sampling as on intervention day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ketosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Subjects drink 3-hydroxybuturate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects drink saline
Intervention Type
Other
Intervention Name(s)
3-hydroxybuturate
Intervention Description
Drink of ketone bodies
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Drink of saline
Primary Outcome Measure Information:
Title
3-hydroxybuturate
Description
blood level of 3-hydroxybuturate
Time Frame
0-270 minutes
Secondary Outcome Measure Information:
Title
Glucose
Description
Glucose tracer kinetics, endogenous glucose production, muscle biopsy
Time Frame
0-270 minutes
Title
lipid metabolism
Description
Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies
Time Frame
0-270 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 20-30 Exclusion Criteria: Smoking alcohol or drug abuse Critically ill
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32794582
Citation
Svart M, Rittig N, Pedersen SB, Jessen N, Moller N. Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial. Diabet Med. 2021 Feb;38(2):e14385. doi: 10.1111/dme.14385. Epub 2020 Sep 22.
Results Reference
derived

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How Orally Consumed 3-hydroxybuturate Alters Metabolism

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