How Orally Consumed 3-hydroxybuturate Alters Metabolism

April 7, 2017 updated by: University of Aarhus

Ketone Bodies Ingested Orally Alter Metabolism for Glucose, Lipid, and Protein

This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 20-30

Exclusion Criteria:

  • Smoking
  • alcohol or drug abuse
  • Critically ill

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Subjects drink 3-hydroxybuturate
Other: 3-hydroxybuturate
Drink of ketone bodies
Placebo Comparator: Placebo
Subjects drink saline
Other: Placebo
Drink of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-hydroxybuturate
Time Frame: 0-270 minutes
blood level of 3-hydroxybuturate
0-270 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose
Time Frame: 0-270 minutes
Glucose tracer kinetics, endogenous glucose production, muscle biopsy
0-270 minutes
lipid metabolism
Time Frame: 0-270 minutes
Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies
0-270 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

April 3, 2017

Study Completion (Actual)

April 3, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-1-10-72-157-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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