Healthy Overweight/ObeseNCT06743009
Metabolic Effects of the Exercise-metabolite Lac-Phe
A study testing N-lactoyl-phenylalanine and NaCl in people with Healthy Overweight/Obese, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Overweight/Obese
- What is being tested?
- N-lactoyl-phenylalanine and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 13 May 2025to 10 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A body mass index (BMI) between 28-35 kg/m2
- Older than 18 years of age
- Hgb within a normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
- Females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device).
Who cannot join
- Medications affecting glucose metabolism (e.g., Saxenda).
- Anemia
- Diabetes
- Ongoing cancer or other acute/chronic serious diseases (PI will determine)
- Inability to understand Danish or English
- Deemed unsuitable to participate by the PI and co-investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Metabolic Effects of the Exercise-metabolite N-lactoyl-phenylalanine (Lac-Phe)
The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35).
The main questions it aims to answer are:
- Does Lac-Phe reduce appetite in humans?
- Does Lac-Phe have glucose-lowering properties in humans?
During the study, participants will:
- receive an intravenous infusion of Lac-Phe on one study day and a NaCl infusion on another study day.
- drink a standard mixed meal
- eat an ad libitum meal test
- answer appetite questionnaires
- indirect calorimetry
- blood samples for hormone and substate analyses
- Conditions
- Healthy Overweight/Obese
- Being tested
- N-lactoyl-phenylalanine, NaCl
- Keywords
- Lac-Phe, Appetite, Glucose metabolisme
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-lactoyl-phenylalanineOther
Also called Lac-Phe
Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)
NaClOther
0.9% isotonic NaCl infusion
| Study group | Role | What they receive |
|---|---|---|
| Lac-Phe | Experimental | Intravenous infusion of Lac-Phe Receives: Other: N-lactoyl-phenylalanine |
| Control | Placebo comparator | Intravenous infusion of NaCl Receives: Other: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
ad libitum meal test
Meal intake (kcal) during the ad libitum meal test
Measured: On the study day, from times 240 minutes and until meal completion as assessed by study participant
Secondary outcomes (15)
Lac-phe
plasma concentrations of lac-phe
Measured: During the study day, time 0-240 minutes
glucose
plasma concentrations of glucose
Measured: During the study day, time 0-240 minutes
lactate
plasma concentrations of lactate
Measured: During the study day, time 0-240 minutes
c-peptide
serum concentrations of c-peptide
Measured: During the study day, time 0-240 minutes
triglycerider
plasma concentrations of triglycerides
Measured: During the study day, time 0-240 minutes
GLP-1
plasma concentration of GLP-1
Measured: During the study day, time 0-240 minutes
GIP
plasma concentrations of GIP
Measured: During the study day, time 0-240 minutes
Ghrelin
plasma concentration of ghrelin
Measured: During the study day, time 0-240 minutes
insulin
serum concentration of insulin
Measured: During the study day, time 0-240 minutes
free fatty acids
Serum concentrations of free fatty acids
Measured: During the study day, time 0-240 minutes
LEAP2
Plasma concentration of liver-expressed antimicrobial peptide 2 (LEAP2)
Measured: From baseline to end of study day (time 0-240 minutes)
Glucagon
Plasma concentration of glucagon
Measured: From baseline to end of study day (time 0-240 minutes)
Gastric emptying assessed by acetaminophen
Plasma concentration of acetaminophen following oral acetaminophen intake
Measured: From baseline to end of study day (time 0-240 minutes)
Subjective appetite - appetite questionaire
We will assess subjective appetite sensations on a visual analog score. Scale range from 1 to 10 centimeters.
Measured: Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes
Energy expenditure
Indirect calorimetry
Measured: After 60 and approx 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 Dec 2024
- Study start13 May 2025
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Overweight/ObeseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743009
- Sponsor's protocol ID
- 1-10-72-185-23
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The corresponding author will make data available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of the Exercise-metabolite N-lactoyl-phenylalanine (Lac-Phe)
- ClinicalTrials.gov ID
- NCT06743009
- Acronym / sponsor ID
- 1-10-72-185-23
- Conditions
- Healthy Overweight/Obese
- Keywords
- Lac-Phe, Appetite, Glucose metabolisme
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 19 Dec 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.
The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35).
The main questions it aims to answer are:
- Does Lac-Phe reduce appetite in humans?
- Does Lac-Phe have glucose-lowering properties in humans?
During the study, participants will:
- receive an intravenous infusion of Lac-Phe on one study day and a NaCl infusion on another study day.
- drink a standard mixed meal
- eat an ad libitum meal test
- answer appetite questionnaires
- indirect calorimetry
- blood samples for hormone and substate analyses
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lac-Phe | Experimental | Other: N-lactoyl-phenylalanineIntravenous infusion of Lac-Phe |
| Control | Placebo comparator | Other: NaClIntravenous infusion of NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A body mass index (BMI) between 28-35 kg/m2
- Older than 18 years of age
- Hgb within a normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
- Females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device).
Key exclusion criteria (6 listed)
- Medications affecting glucose metabolism (e.g., Saxenda).
- Anemia
- Diabetes
- Ongoing cancer or other acute/chronic serious diseases (PI will determine)
- Inability to understand Danish or English
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 |
|---|---|---|
| N-lactoyl-phenylalanineAlso: Lac-PheIntravenous infusion of N-lactoyl-phenylalanine (Lac-Phe) | Other | Lac-Phe |
| NaCl0.9% isotonic NaCl infusion | Other | Control |
Primary outcome
ad libitum meal test
Time frame: On the study day, from times 240 minutes and until meal completion as assessed by study participant
Meal intake (kcal) during the ad libitum meal test
15 secondary outcomes
Lac-phe
Time frame: During the study day, time 0-240 minutes
glucose
Time frame: During the study day, time 0-240 minutes
lactate
Time frame: During the study day, time 0-240 minutes
c-peptide
Time frame: During the study day, time 0-240 minutes
triglycerider
Time frame: During the study day, time 0-240 minutes
GLP-1
Time frame: During the study day, time 0-240 minutes
GIP
Time frame: During the study day, time 0-240 minutes
Ghrelin
Time frame: During the study day, time 0-240 minutes
insulin
Time frame: During the study day, time 0-240 minutes
free fatty acids
Time frame: During the study day, time 0-240 minutes
LEAP2
Time frame: From baseline to end of study day (time 0-240 minutes)
Glucagon
Time frame: From baseline to end of study day (time 0-240 minutes)
Gastric emptying assessed by acetaminophen
Time frame: From baseline to end of study day (time 0-240 minutes)
Subjective appetite - appetite questionaire
Time frame: Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes
Energy expenditure
Time frame: After 60 and approx 180 minutes
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 27 Mar 2026.
- Individual participant dataSharing planned: No. The corresponding author will make data available on reasonable request.
Related trials for Healthy Overweight/Obese
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-lactoyl-phenylalanine and NaCl in people with Healthy Overweight/Obese, 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 4 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: finished, as of the sponsor's last update on 27 Mar 2026. 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?
ad libitum meal test (time frame: On the study day, from times 240 minutes and until meal completion as assessed by study participant). 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 27 Mar 2026.