Metabolic SyndromeNCT06589856
Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
A study testing LAC5, LAC10 and LAC20 in people with Metabolic Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- LAC5, LAC10 and LAC20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2024to Jan 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years
- Written and oral consent
- Healthy
Who cannot join
- HbA1c > 39
- Taking medicine
- Any diseases
- Allergy to paracetamol
- Doesn't speak or understand Danish.
- Special diets
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center Aarhus, Aarhus University Hospital
Aarhus, Aarhus N, 8200
About this study
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.
Read the 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
- Conditions
- Metabolic Syndrome
- Being tested
- Placebo, LAC5, LAC10, LAC20
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo (300 mL salt water, NaCl) = CTR
LAC5Dietary supplement
5 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5
LAC10Dietary supplement
10 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10
LAC20Dietary supplement
20 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20
| Study group | Role | What they receive |
|---|---|---|
| CTR | Placebo comparator | Not described Receives: Dietary Supplement: Placebo; Dietary Supplement: LAC5; Dietary Supplement: LAC10; Dietary Supplement: LAC20 |
| LAC5 | Experimental | Not described Receives: Dietary Supplement: Placebo; Dietary Supplement: LAC5; Dietary Supplement: LAC10; Dietary Supplement: LAC20 |
| LAC10 | Experimental | Not described Receives: Dietary Supplement: Placebo; Dietary Supplement: LAC5; Dietary Supplement: LAC10; Dietary Supplement: LAC20 |
| LAC20 | Experimental | Not described Receives: Dietary Supplement: Placebo; Dietary Supplement: LAC5; Dietary Supplement: LAC10; Dietary Supplement: LAC20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean insulin concentration
Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.
Measured: 60 minutes
Secondary outcomes (8)
Difference in blood glucose
Measured: 0-180 minutes after the intervention
Difference in GLP-1
Measured: 0-180 minutes after the intervention
Difference in GIP
Measured: 0-180 minutes after the intervention
Difference in LEAP2
Measured: 0-180 minutes after the intervention
Difference in glucagon
Measured: 0-180 minutes after the intervention
Difference in c-peptide
Measured: 0-180 minutes after the intervention
Difference in gastric emptying rate
Acetaminophen test
Measured: 0-180 minutes after the intervention
Difference in appetite sensation
VAS (visual analoge scale)
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized single-blinded, placebo-controlled crossover study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Hohwü Voigt, University of Aarhus
- Investigators
- Esben Sondergaard, Principal investigator, Aarhus University, Steno Diabetes Center Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589856
- Sponsor's protocol ID
- LAMETA-DOSE-RESPONSE
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?
- ClinicalTrials.gov ID
- NCT06589856
- Acronym / sponsor ID
- LAMETA-DOSE-RESPONSE
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized single-blinded, placebo-controlled crossover study.
| Arm | Type | Receives |
|---|---|---|
| CTR | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: LAC5, Dietary Supplement: LAC10, Dietary Supplement: LAC20 |
| LAC5 | Experimental | Dietary Supplement: Placebo, Dietary Supplement: LAC5, Dietary Supplement: LAC10, Dietary Supplement: LAC20 |
| LAC10 | Experimental | Dietary Supplement: Placebo, Dietary Supplement: LAC5, Dietary Supplement: LAC10, Dietary Supplement: LAC20 |
| LAC20 | Experimental | Dietary Supplement: Placebo, Dietary Supplement: LAC5, Dietary Supplement: LAC10, Dietary Supplement: LAC20 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years
- Written and oral consent
- Healthy
Key exclusion criteria (6 listed)
- HbA1c > 39
- Taking medicine
- Any diseases
- Allergy to paracetamol
- Doesn't speak or understand 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 |
|---|---|---|
| PlaceboPlacebo (300 mL salt water, NaCl) = CTR | Dietary supplement | CTR, LAC10, LAC20, LAC5 |
| LAC55 g lactate (300 mL lactate drink = 5 g D/L-lactate bound to Na) = LAC5 | Dietary supplement | CTR, LAC10, LAC20, LAC5 |
| LAC1010 g lactate (300 mL lactate drink = 10 g D/L-lactate bound to Na) = LAC10 | Dietary supplement | CTR, LAC10, LAC20, LAC5 |
| LAC2020 g lactate (300 mL lactate drink = 20 g D/L-lactate bound to Na) = LAC20 | Dietary supplement | CTR, LAC10, LAC20, LAC5 |
Primary outcome
Difference in mean insulin concentration
Time frame: 60 minutes
Difference in mean insulin concentration 60 minutes after the intervention between CTR and LAC5, LAC10, and LAC20.
8 secondary outcomes
Difference in blood glucose
Time frame: 0-180 minutes after the intervention
Difference in GLP-1
Time frame: 0-180 minutes after the intervention
Difference in GIP
Time frame: 0-180 minutes after the intervention
Difference in LEAP2
Time frame: 0-180 minutes after the intervention
Difference in glucagon
Time frame: 0-180 minutes after the intervention
Difference in c-peptide
Time frame: 0-180 minutes after the intervention
Difference in gastric emptying rate
Time frame: 0-180 minutes after the intervention
Difference in appetite sensation
Time frame: 0-180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Esben Sondergaard principal investigator
Aarhus University, Steno Diabetes Center Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAC5, LAC10 and LAC20 in people with Metabolic Syndrome, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esben Søndergaard (004528730943, esben.sondergaard@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean insulin concentration (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.