Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?

Not Applicable

Not yet recruiting

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: LAC5; Dietary Supplement: LAC10; Dietary Supplement: LAC20

• Registration Number: NCT06589856
• Lead Sponsor: University of Aarhus

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

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-10
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LAC10	Placebo	-
LAC10	LAC5	-
CTR	Placebo	-
CTR	LAC5	-
CTR	LAC10	-
CTR	LAC20	-
LAC5	Placebo	-
LAC5	LAC5	-
LAC5	LAC10	-
LAC5	LAC20	-
LAC10	LAC10	-
LAC10	LAC20	-
LAC20	Placebo	-
LAC20	LAC5	-
LAC20	LAC10	-
LAC20	LAC20	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Difference in blood glucose	0-180 minutes after the intervention
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 glucagon	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)

Trial Locations

Locations (1)

Steno Diabetes Center Aarhus, Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus N, Denmark