Clinical trial NCT06589856: Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
Official title: Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized single-blinded, placebo-controlled crossover study.
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Difference in mean insulin concentration
timeFrame: 60 minutes
Secondary outcomes:
measure: Difference in blood glucose
timeFrame: 0-180 minutes after the intervention
measure: Difference in GLP-1
timeFrame: 0-180 minutes after the intervention
measure: Difference in GIP
timeFrame: 0-180 minutes after the intervention
measure: Difference in LEAP2
timeFrame: 0-180 minutes after the intervention
measure: Difference in glucagon
timeFrame: 0-180 minutes after the intervention
measure: Difference in c-peptide
timeFrame: 0-180 minutes after the intervention
measure: Difference in gastric emptying rate
timeFrame: 0-180 minutes after the intervention
measure: Difference in appetite sensation
timeFrame: 0-180 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus, Aarhus University Hospital
state: Aarhus N
Study officials:
affiliation: Aarhus University, Steno Diabetes Center Aarhus
name: Esben Sondergaard
role: PRINCIPAL_INVESTIGATOR
References: