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Lactate in the Gut

Lactate in the Gut

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04299815
Enrollment
10
Registered
2020-03-09
Start date
2020-04-01
Completion date
2020-07-29
Last updated
2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Hyperlactatemia, Lactate

Keywords

lactate, metabolism, Gastric emptying, GDF-15, insulin, incretin hormones

Brief summary

Lactate is formed naturally in the body in example during physical activity. However, lactate is also formed during food fermentation where certain bacterial strains form lactate. Lactate can also be produced chemically. An example of this is Ringer-lactate which is used for volume replacement when treating dehydrated patients. As a source of carbon-molecules, lactate is believed to be an important oxidative fuel source in all major organs and yields adenosine triphosphate (ATP) production through Krebs cycle, the Electron Transport Chain in the mitochondria as well as by being a key precursor for gluconeogenesis. Metformin is the first drug of choice for type 2 diabetes treatment. Use of metformin often results in a small but significant weight loss in overweight users. It is known that metformin increases the lactate concentration in the gut. It is also known also know that metformin use is associated with an increase in blood concentrations of growth differentiation factor 15 (GDF-15). Receptors for GDF-15 can be found in parts of the brain associated with control of appetite. In rats increases in \[GDF-15\] results in a decrease in appetite and thus weight loss. GDF-15 is thought to be involved in the normal energy homeostasis. With this study the investigators want to examine the hormonal, metabolic and mechanical effects of lactate in the gut in healthy volunteers. Our hypothesis is that lactate has beneficial effects which may be though an increase in GDF-15 in the blood. Volunteers will undergo two study days separated by at least 7 days and a maximum of 1 month. * On day one volunteers will drink a sodium-lactate solution (intervention). The investigators will also administrate 1500mg paracetamol to assess gastric emptying and do blood samples over 4 hours. The investigators measure \[lactate\] every 15 min. Every hour the investigators will ask volunteers questions regarding hunger and thoughts of future food intake (questionnaire). After 4 hours of blood sampling the investigators will serve volunteers an all-you-can-eat meal of sandwich and measure how must they ate. * On day two volunteers will drink a sodium chloride solution. Furthermore, the investigators administrate intravenous D/L sodium lactate in order to reach the same plasma \[lactate\] on day 2 as was done on day 1. The rest of day two is identical to day 1.

Interventions

DRUGOral Sodium Lactate

25 grams of D/L lactate dissolved in 300mL water.

DRUGIntravenous sodium lactate

intravenous sodium lactate + oral sodium-chlorid solution

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Male gender * Age 18-50 years * BMI 20-30 kg/m2 * In good health with no daily use of prescription medicine based on medical history, clinical examination and blood samples. * Spoken and written informed consent

Exclusion criteria

* Chronic illness or daily use of prescription medicine . * Abnormal screening blood samples as judged by the PI * Does not understand or speak Danish

Design outcomes

Primary

MeasureTime frameDescription
GDF-154 hoursDifference in \[GDF-15\] between intervention and placebo

Secondary

MeasureTime frameDescription
Gastric inhibitory peptide (GIP)4 hoursDifference in plasma \[GIP\] between intervention and placebo
free fatty acid4 hoursDifference in \[free fatty acid \] between intervention and placebo
cholecystokinin4 hoursDifference in \[cholecystokinin\] between intervention and placebo
Ghrelin4 hoursDifference in \[Ghrelin\] between intervention and placebo
glucagon-like peptide -14 hoursDifference in \[glucagon-like peptide -1\] between intervention and placebo
C-peptide4 hoursDifference in \[C-peptide\] between intervention and placebo
glucose4 hoursDifference in \[glucose\] between intervention and placebo
gastric emptying4 hours\[Paracetamol\] to asses gastric emptying
Evaluation of hunger4 hoursEvaluation of hunger, thoughts of future food intake ect using a questionnaire
Gastrin4 hoursDifference in \[Gastrin\] between intervention and placebo

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026