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Completed

NCT Number: NCT03935841

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

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.

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Key information

Conditions

Healthy Acid-Base Imbalance Acidosis Incretin Effect Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Diabetes and Hormone Diseases (DoH)

Aarhus N, 8200, Denmark

About this study

An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.

  • blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-OHB salt (NaCl)

Dietary Supplement

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

Primary outcomes

  1. plasma insulin

    Time frame: 180 minutes

    incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}

Secondary outcomes

  1. Plasma Glucagon

    Time frame: 180 minutes

    iAUC and concentrations of (Glucagon {pg/ml}

  2. Gastric emptying

    Time frame: 180 minutes

    Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l}

  3. Urine 3-OHB

    Time frame: 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

  4. Plasma GLP1

    Time frame: 180 minutes

    iAUC and concentrations of GLP-1 {pmol/l},

  5. Plasma GIP

    Time frame: 180 minutes

    iAUC and concentrations of GIP {pmol/l},

  6. Plasma glucose

    Time frame: 180 minutes

    iAUC and concentrations of glucose {mmol/l},

  7. Plasma free fatty acids

    Time frame: 180 minutes

    iAUC and concentrations of free fatty acids {mmol/l},

  8. Plasma 3-OHB

    Time frame: 180 minutes

    iAUC and concentrations of 3-OHB {mmol/l})

  9. Plasma Ghrelin

    Time frame: 180 minutes

    iAUC and concentrations of Ghrelin {ng/l})

  10. Plasma PYY

    Time frame: 180 minutes

    iAUC and concentrations of PYY {pg/ml})

  11. height

    Time frame: at time 0 minutes

    height {meters}

  12. weight

    Time frame: at time 0 minutes

    weight {kg}

  13. BMI

    Time frame: time 0 minutes

    Body mass index = weight/height^2

  14. Blood pressure

    Time frame: time 0 minutes and 180 minutes

    Arm blood pressure

  15. Satiety questionnaire (Blundell et al. 2010)

    Time frame: At 0, 60, 120, and 180 minutes

    VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption

  16. Ad libitum food intake

    Time frame: at time = 180 minutes

    gram (and kcal) intake of an ad libitum meal (sandwich)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 2, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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