Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589856
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 173 pmolL in mean insulin concentrations at time 60 minutes with a SD of 183 α005 β080 To account for potential missing values we will include a total of 12 participants
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 173 pmolL in mean insulin concentrations at time 60 minutes with a SD of 183 α005 β080 To account for potential missing values we will include a total of 12 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None