LactateNCT04299815
Lactate in the Gut
A study testing Oral Sodium Lactate and Intravenous sodium lactate in people with Lactate and Healthy, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lactate, Healthy, Hyperlactatemia
- What is being tested?
- Oral Sodium Lactate and Intravenous sodium lactate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2020to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Chronic illness or daily use of prescription medicine .
- Abnormal screening blood samples as judged by the PI
- Does not understand or speak Danish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Lactate, Healthy, Hyperlactatemia
- Being tested
- Oral Sodium Lactate, Intravenous sodium lactate
- Keywords
- lactate, metabolism, Gastric emptying, GDF-15, insulin, incretin hormones
- Medical subject headings
- Hyperlactatemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Sodium LactateDrug
25 grams of D/L lactate dissolved in 300mL water.
Intravenous sodium lactateDrug
intravenous sodium lactate + oral sodium-chlorid solution
| Study group | Role | What they receive |
|---|---|---|
| Oral lactate | Active comparator | Sodium D/L lactate solution, 25g/L in 300mL water Receives: Drug: Oral Sodium Lactate |
| Iso-lactic intravenous lactate infusion | Placebo comparator | iv sodium D/L lactate to elevate [lactate] to the same levels as measured on day 1 + oral sodium chloride, 300 mL Receives: Drug: Intravenous sodium lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
GDF-15
Difference in [GDF-15] between intervention and placebo
Measured: 4 hours
Secondary outcomes (10)
glucagon-like peptide -1
Difference in [glucagon-like peptide -1] between intervention and placebo
Measured: 4 hours
Gastric inhibitory peptide (GIP)
Difference in plasma [GIP] between intervention and placebo
Measured: 4 hours
free fatty acid
Difference in [free fatty acid ] between intervention and placebo
Measured: 4 hours
cholecystokinin
Difference in [cholecystokinin] between intervention and placebo
Measured: 4 hours
Ghrelin
Difference in [Ghrelin] between intervention and placebo
Measured: 4 hours
Gastrin
Difference in [Gastrin] between intervention and placebo
Measured: 4 hours
C-peptide
Difference in [C-peptide] between intervention and placebo
Measured: 4 hours
glucose
Difference in [glucose] between intervention and placebo
Measured: 4 hours
gastric emptying
[Paracetamol] to asses gastric emptying
Measured: 4 hours
Evaluation of hunger
Evaluation of hunger, thoughts of future food intake ect using a questionnaire
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Apr 2020
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LactateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaj Rittig, postdoc, Study chair, Steno Diabetes Center Aarhus (SDCA), Aarhus universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299815
- Sponsor's protocol ID
- 1-10-72-8-20
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14.
PubMed 37844838Pedersen MGB, Sondergaard E, Nielsen CB, Johannsen M, Gormsen LC, Moller N, Jessen N, Rittig N. Oral lactate slows gastric emptying and suppresses appetite in young males. Clin Nutr. 2022 Feb;41(2):517-525. doi: 10.1016/j.clnu.2021.12.032. Epub 2021 Dec 24.
PubMed 35016146
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate in the Gut
- ClinicalTrials.gov ID
- NCT04299815
- Acronym / sponsor ID
- 1-10-72-8-20
- Conditions
- Lactate, Healthy, Hyperlactatemia
- Keywords
- lactate, metabolism, Gastric emptying, GDF-15, insulin, incretin hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral lactate | Active comparator | Drug: Oral Sodium LactateSodium D/L lactate solution, 25g/L in 300mL water |
| Iso-lactic intravenous lactate infusion | Placebo comparator | Drug: Intravenous sodium lactateiv sodium D/L lactate to elevate [lactate] to the same levels as measured on day 1 + oral sodium chloride, 300 mL |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Chronic illness or daily use of prescription medicine .
- Abnormal screening blood samples as judged by the PI
- Does not understand or speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Sodium Lactate25 grams of D/L lactate dissolved in 300mL water. | Drug | Oral lactate |
| Intravenous sodium lactateintravenous sodium lactate + oral sodium-chlorid solution | Drug | Iso-lactic intravenous lactate infusion |
Primary outcome
GDF-15
Time frame: 4 hours
Difference in [GDF-15] between intervention and placebo
10 secondary outcomes
glucagon-like peptide -1
Time frame: 4 hours
Gastric inhibitory peptide (GIP)
Time frame: 4 hours
free fatty acid
Time frame: 4 hours
cholecystokinin
Time frame: 4 hours
Ghrelin
Time frame: 4 hours
Gastrin
Time frame: 4 hours
C-peptide
Time frame: 4 hours
glucose
Time frame: 4 hours
gastric emptying
Time frame: 4 hours
Evaluation of hunger
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 37844838Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14.
- Derived from this study: PubMed 35016146Pedersen MGB, Sondergaard E, Nielsen CB, Johannsen M, Gormsen LC, Moller N, Jessen N, Rittig N. Oral lactate slows gastric emptying and suppresses appetite in young males. Clin Nutr. 2022 Feb;41(2):517-525. doi: 10.1016/j.clnu.2021.12.032. Epub 2021 Dec 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaj Rittig, postdoc study chair
Steno Diabetes Center Aarhus (SDCA), Aarhus universitetshospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Sodium Lactate and Intravenous sodium lactate in people with Lactate and Healthy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDF-15 (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299815, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.