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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935841
• Other study ID #: 1-10-72-56-19
• Status: Completed
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy

• 19<BMI<30

• written og oral consent

• No allergies to paracetamol

Exclusion Criteria:

• Chronic disease or daily medical treatment

• Daily intake of ketones or ketogenic diets

• Speaks and understands Danish

• Screening blood sample abnormalities

Related Conditions & MeSH terms

• Healthy
• Incretin Effect
• Ketosis

Intervention

Dietary Supplement:
• 3-OHB salt (NaCl)
36 gram 3-OHB salt diluted in 500 ml sterile water

Locations

Country	Name	City	State
Denmark	Department of Diabetes and Hormone Diseases (DoH)	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma insulin	incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}	180 minutes
Secondary	Plasma Glucagon	iAUC and concentrations of (Glucagon {pg/ml}	180 minutes
Secondary	Gastric emptying	Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l}	180 minutes
Secondary	Urine 3-OHB	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	180 minutes
Secondary	Plasma GLP1	iAUC and concentrations of GLP-1 {pmol/l},	180 minutes
Secondary	Plasma GIP	iAUC and concentrations of GIP {pmol/l},	180 minutes
Secondary	Plasma glucose	iAUC and concentrations of glucose {mmol/l},	180 minutes
Secondary	Plasma free fatty acids	iAUC and concentrations of free fatty acids {mmol/l},	180 minutes
Secondary	Plasma 3-OHB	iAUC and concentrations of 3-OHB {mmol/l})	180 minutes
Secondary	Plasma Ghrelin	iAUC and concentrations of Ghrelin {ng/l})	180 minutes
Secondary	Plasma PYY	iAUC and concentrations of PYY {pg/ml})	180 minutes
Secondary	height	height {meters}	at time 0 minutes
Secondary	weight	weight {kg}	at time 0 minutes
Secondary	BMI	Body mass index = weight/height^2	time 0 minutes
Secondary	Blood pressure	Arm blood pressure	time 0 minutes and 180 minutes
Secondary	Satiety questionnaire (Blundell et al. 2010)	VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption	At 0, 60, 120, and 180 minutes
Secondary	Ad libitum food intake	gram (and kcal) intake of an ad libitum meal (sandwich)	at time = 180 minutes