NCT04299815

Lactate in the Gut

Completed NA Last updated 30 September 2020

What this trial tests

NA trial testing Oral Sodium Lactate in Lactate in 10 participants. Completed in 29 July 2020.

Timeline

1 April 2020

Primary endpoint
29 July 2020

29 July 2020

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	1 April 2020
Primary completion	29 July 2020
Estimated completion	29 July 2020
Sites	1 location across Denmark

Drugs / interventions tested

• Oral Sodium Lactate
• Intravenous sodium lactate

Conditions studied

• Lactate — all drugs for Lactate →
• Healthy — all drugs for Healthy →
• Hyperlactatemia — all drugs for Hyperlactatemia →

Sponsor

University of Aarhus

Who can join

Adults 18 to 50, male only, with Lactate or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oral lactate slows gastric emptying and suppresses appetite in young males.
   Pedersen MGB, Søndergaard E, Nielsen CB, Johannsen M, et al · · 2022 · cited 27× · PMID 35016146 · DOI 10.1016/j.clnu.2021.12.032
2. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and β-hydroxybutyrate in healthy young males.
   Pedersen MGB, Lauritzen ES, Svart MV, Støy J, et al · · 2023 · cited 13× · PMID 37844838 · DOI 10.1016/j.ajcnut.2023.10.007
3. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y