NCT02917252

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2017

Completed
Last Updated

April 10, 2017

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

September 27, 2016

Last Update Submit

April 7, 2017

Conditions

Acute Ketosis

Outcome Measures

Primary Outcomes (1)

  • 3-hydroxybuturate

    blood level of 3-hydroxybuturate

    0-270 minutes

Secondary Outcomes (2)

  • Glucose

    0-270 minutes

  • lipid metabolism

    0-270 minutes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Subjects drink 3-hydroxybuturate

Other: 3-hydroxybuturate

Placebo

PLACEBO COMPARATOR

Subjects drink saline

Other: Placebo

Interventions

3-hydroxybuturateOTHER

Drink of ketone bodies

Intervention
PlaceboOTHER

Drink of saline

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 20-30

You may not qualify if:

  • Smoking
  • alcohol or drug abuse
  • Critically ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 32794582DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

February 1, 2017

Primary Completion

April 3, 2017

Study Completion

April 3, 2017

Last Updated

April 10, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)