Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
NCT ID: NCT06589856
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
12 participants
INTERVENTIONAL
2024-10-31
2025-01-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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CTR
Placebo
Placebo (300 mL salt water, NaCl) = CTR
LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
LAC5
Placebo
Placebo (300 mL salt water, NaCl) = CTR
LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
LAC10
Placebo
Placebo (300 mL salt water, NaCl) = CTR
LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
LAC20
Placebo
Placebo (300 mL salt water, NaCl) = CTR
LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
Interventions
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Placebo
Placebo (300 mL salt water, NaCl) = CTR
LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
Eligibility Criteria
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Inclusion Criteria
* Written and oral consent
* Healthy
Exclusion Criteria
* Taking medicine
* Any diseases
* Allergy to paracetamol
* Doesn't speak or understand Danish.
* Special diets
18 Years
75 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Jens Hohwü Voigt
MD, PhD student
Principal Investigators
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Esben Sondergaard
Role: PRINCIPAL_INVESTIGATOR
Aarhus University, Steno Diabetes Center Aarhus
Locations
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Steno Diabetes Center Aarhus, Aarhus University Hospital
Aarhus, Aarhus N, Denmark
Countries
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Central Contacts
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Other Identifiers
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LAMETA-DOSE-RESPONSE
Identifier Type: -
Identifier Source: org_study_id
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