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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTR | Placebo Comparator |
| |
| LAC5 | Experimental |
| |
| LAC10 | Experimental |
| |
| LAC20 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo (300 mL salt water, NaCl) = CTR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean insulin concentration | Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in blood glucose | 0-180 minutes after the intervention | |
| Difference in GLP-1 | 0-180 minutes after the intervention | |
| Difference in GIP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esben Søndergaard | Contact | 004528730943 | esben.sondergaard@clin.au.dk | |
| Jens H Voigt | Contact | 004526395294 | Jens.voigt@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Esben Sondergaard | Aarhus University, Steno Diabetes Center Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus, Aarhus University Hospital | Aarhus | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Randomized single-blinded, placebo-controlled crossover study.
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| 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 |
|
| 0-180 minutes after the intervention |
| Difference in LEAP2 | 0-180 minutes after the intervention |
| Difference in glucagon | 0-180 minutes after the intervention |
| Difference in c-peptide | 0-180 minutes after the intervention |
| Difference in gastric emptying rate | Acetaminophen test | 0-180 minutes after the intervention |
| Difference in appetite sensation | VAS (visual analoge scale) | 0-180 minutes |
| D009750 |
| Nutritional and Metabolic Diseases |