How Orally Consumed 3-hydroxybuturate Alters Metabolism

Acute Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917252
• Other study ID #: RM-1-10-72-157-16
• Status: Completed
• Phase: N/A
• First received: September 27, 2016
• Last updated: April 7, 2017
• Start date: February 1, 2017
• Est. completion date: April 3, 2017

Study information

• Verified date: September 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• BMI 20-30

Exclusion Criteria:

• Smoking

• alcohol or drug abuse

• Critically ill

Related Conditions & MeSH terms

• Acute Ketosis

Intervention

Other:
• 3-hydroxybuturate
Drink of ketone bodies
• Placebo
Drink of saline

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-hydroxybuturate	blood level of 3-hydroxybuturate	0-270 minutes
Secondary	Glucose	Glucose tracer kinetics, endogenous glucose production, muscle biopsy	0-270 minutes
Secondary	lipid metabolism	Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies	0-270 minutes