Steno Diabetes Center Aarhus, Aarhus University Hospital
Aarhus, Aarhus N, 8200, Denmark
NCT Number: NCT06589856
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Aarhus, Aarhus N, 8200, Denmark
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo (300 mL salt water, NaCl) = CTR
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
Time frame: 60 minutes
Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Time frame: 0-180 minutes after the intervention
Acetaminophen test
Time frame: 0-180 minutes
VAS (visual analoge scale)
Contact information is provided by the study sponsor or research team.
Esben Søndergaard
CONTACT
Jens H Voigt
CONTACT
University of Aarhus
Other
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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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