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Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).

NCT03935841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-11-03

No results posted yet for this study

Summary

An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:

1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.

The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.

Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.

Conditions

  • Healthy
  • Incretin Effect
  • Ketosis

Interventions

DIETARY_SUPPLEMENT

3-OHB salt (NaCl)

36 gram 3-OHB salt diluted in 500 ml sterile water

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Jessen, Professor · Aarhus University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-07
Primary Completion
2019-11-01
Completion
2020-03-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935841 on ClinicalTrials.gov