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NCT Number: NCT06589856

Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?

To investigate whether there is a linear dose-response relationship between oral lactate and its effects on gut hormone secretion, motility, and appetite.

Hypothesis Oral lactate administration affects gut hormone secretion, insulin levels, motility, appetite sensation and the amount of food intake in a linear dose-response relationship.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

About this study

The participants will meet up fasting at the Steno Diabetes Centre Aarhus Research Lab. Immediately after arrival, they will be placed in a bed. The four trial days will be completely alike, besides the interventions.

The participants will have one intravenous (iv.) access placed in the elbow on the four trial days for a continuous drawing of blood samples throughout the trial day.

Before drinking the intervention, baseline blood samples will be drawn. Immediately after drinking the intervention, the participants will take 1500 mg paracetamol to determine ventricular emptying rate through the acetaminophen test.

After this, the participants can lay in their bed and watch TV, Ipad or work on their computer. Blood samples will be collected at 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes after the intervention. Appetite sensations will be measured by a visual analog scales (VAS). After 3 hours the trial day is finished, and the participants can go home.

Before and after each trial day the participants will collect a fecal sample.

We will use ANOVA and mixed model regression analyses for comparing the four groups.

Based on a previous study we will need 11 individuals to detect a difference of 17,3 pmol/L in mean insulin concentrations at time 60 minutes, with a SD of 18,3 (α=0.05, β=0.80). To account for potential missing values, we will include a total of 12 participants

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-75 years
  • Written and oral consent
  • Healthy

Exclusion criteria

  • HbA1c > 39
  • Taking medicine
  • Any diseases
  • Allergy to paracetamol
  • Doesn't speak or understand Danish.
  • Special diets

Treatment and study plan

Placebo

Dietary Supplement

Placebo (300 mL salt water, NaCl) = CTR

LAC5

Dietary Supplement

5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5

LAC10

Dietary Supplement

10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10

LAC20

Dietary Supplement

20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20

Primary outcomes

  1. Difference in mean insulin concentration

    Time frame: 60 minutes

    Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.

Secondary outcomes

  1. Difference in blood glucose

    Time frame: 0-180 minutes after the intervention

  2. Difference in GLP-1

    Time frame: 0-180 minutes after the intervention

  3. Difference in GIP

    Time frame: 0-180 minutes after the intervention

  4. Difference in LEAP2

    Time frame: 0-180 minutes after the intervention

  5. Difference in glucagon

    Time frame: 0-180 minutes after the intervention

  6. Difference in c-peptide

    Time frame: 0-180 minutes after the intervention

  7. Difference in gastric emptying rate

    Time frame: 0-180 minutes after the intervention

    Acetaminophen test

  8. Difference in appetite sensation

    Time frame: 0-180 minutes

    VAS (visual analoge scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Esben Søndergaard

CONTACT

[email protected]

004528730943

Jens H Voigt

CONTACT

[email protected]

004526395294

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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