Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, LAC5, LAC10, LAC20.
- Who it may be relevant to
- Registry conditions: Metabolic Syndrome. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Placebo
Placebo (300 mL salt water, NaCl) = CTR - Dietary supplement LAC5
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5 - Dietary supplement LAC10
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10 - Dietary supplement LAC20
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
Primary outcome measures
- Difference in mean insulin concentration [Time frame: 60 minutes]
Secondary outcome measures (8)
- Difference in blood glucose [Time frame: 0-180 minutes after the intervention]
- Difference in GLP-1 [Time frame: 0-180 minutes after the intervention]
- Difference in GIP [Time frame: 0-180 minutes after the intervention]
- Difference in LEAP2 [Time frame: 0-180 minutes after the intervention]
- Difference in glucagon [Time frame: 0-180 minutes after the intervention]
- Difference in c-peptide [Time frame: 0-180 minutes after the intervention]
- Difference in gastric emptying rate [Time frame: 0-180 minutes after the intervention]
- Difference in appetite sensation [Time frame: 0-180 minutes]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Steno Diabetes Center Aarhus, Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06589856 · LAMETA-DOSE-RESPONSE