Metabolic Syndrome
Conditions
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo (300 mL salt water, NaCl) = CTR
DIETARY_SUPPLEMENTLAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
DIETARY_SUPPLEMENTLAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
DIETARY_SUPPLEMENTLAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized single-blinded, placebo-controlled crossover study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean insulin concentration | 60 minutes | Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in GLP-1 | 0-180 minutes after the intervention | — |
| Difference in GIP | 0-180 minutes after the intervention | — |
| Difference in LEAP2 | 0-180 minutes after the intervention | — |
| Difference in blood glucose | 0-180 minutes after the intervention | — |
| Difference in c-peptide | 0-180 minutes after the intervention | — |
| Difference in gastric emptying rate | 0-180 minutes after the intervention | Acetaminophen test |
| Difference in appetite sensation | 0-180 minutes | VAS (visual analoge scale) |
| Difference in glucagon | 0-180 minutes after the intervention | — |
Countries
Denmark
Contacts
Primary ContactEsben Søndergaard
Backup ContactJens H Voigt
Outcome results
None listed