Trials / Completed
CompletedNCT03935841
Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Detailed description
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 3-OHB salt (NaCl) | 36 gram 3-OHB salt diluted in 500 ml sterile water |
Timeline
- Start date
- 2019-06-07
- Primary completion
- 2019-11-01
- Completion
- 2020-03-01
- First posted
- 2019-05-02
- Last updated
- 2020-11-03
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03935841. Inclusion in this directory is not an endorsement.