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

Not Applicable

Completed

• Conditions: Incretin Effect; Healthy; Ketosis
• Interventions: Dietary Supplement: 3-OHB salt (NaCl)

• Registration Number: NCT03935841
• Lead Sponsor: University of Aarhus

Brief 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-02
• Study Start: 2019-06-07
• Primary Completion: 2019-11-01
• Study Completion: 2020-03-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• healthy
• 19<BMI<30
• written og oral consent
• No allergies to paracetamol

Read More

Exclusion Criteria

• Chronic disease or daily medical treatment
• Daily intake of ketones or ketogenic diets
• Speaks and understands Danish
• Screening blood sample abnormalities

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3-OHB orally	3-OHB salt (NaCl)	36 gram 3-OHB salt consumed orally
3-OHB intravenously	3-OHB salt (NaCl)	Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm.

Primary Outcome Measures

Name	Time	Method
plasma insulin	180 minutes	incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}

Secondary Outcome Measures

Name	Time	Method
Satiety questionnaire (Blundell et al. 2010)	At 0, 60, 120, and 180 minutes	VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption
Plasma Glucagon	180 minutes	iAUC and concentrations of (Glucagon {pg/ml}
Gastric emptying	180 minutes	Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l}
Urine 3-OHB	180 minutes	Excretion rates {gram/hour} will be estimated as = urine output {L} x urine 3-OHB concentration {mmol/l} x 0.1041 {g/mmol}/180 minutes
Plasma GLP1	180 minutes	iAUC and concentrations of GLP-1 {pmol/l},
Plasma GIP	180 minutes	iAUC and concentrations of GIP {pmol/l},
Plasma free fatty acids	180 minutes	iAUC and concentrations of free fatty acids {mmol/l},
Blood pressure	time 0 minutes and 180 minutes	Arm blood pressure
Plasma glucose	180 minutes	iAUC and concentrations of glucose {mmol/l},
Plasma 3-OHB	180 minutes	iAUC and concentrations of 3-OHB {mmol/l})
weight	at time 0 minutes	weight {kg}
BMI	time 0 minutes	Body mass index = weight/height\^2
Ad libitum food intake	at time = 180 minutes	gram (and kcal) intake of an ad libitum meal (sandwich)
Plasma Ghrelin	180 minutes	iAUC and concentrations of Ghrelin {ng/l})
Plasma PYY	180 minutes	iAUC and concentrations of PYY {pg/ml})
height	at time 0 minutes	height {meters}

Trial Locations

Locations (1)

Department of Diabetes and Hormone Diseases (DoH); 🇩🇰 Aarhus N, Denmark