Metabolic Effects of the Exercise-metabolite Lac-Phe

March 23, 2026 updated by: University of Aarhus

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • SDCA research laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lac-Phe
Intravenous infusion of Lac-Phe
Other: N-lactoyl-phenylalanine
Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)
Other Names:
  • Lac-Phe
Placebo Comparator: Control
Intravenous infusion of NaCl
Other: NaCl
0.9% isotonic NaCl infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
On the study day, from times 240 minutes and until meal completion as assessed by study participant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lac-phe
Time Frame: During the study day, time 0-240 minutes
plasma concentrations of lac-phe
During the study day, time 0-240 minutes
glucose
Time Frame: During the study day, time 0-240 minutes
plasma concentrations of glucose
During the study day, time 0-240 minutes
lactate
Time Frame: During the study day, time 0-240 minutes
plasma concentrations of lactate
During the study day, time 0-240 minutes
c-peptide
Time Frame: During the study day, time 0-240 minutes
serum concentrations of c-peptide
During the study day, time 0-240 minutes
triglycerider
Time Frame: During the study day, time 0-240 minutes
plasma concentrations of triglycerides
During the study day, time 0-240 minutes
GLP-1
Time Frame: During the study day, time 0-240 minutes
plasma concentration of GLP-1
During the study day, time 0-240 minutes
GIP
Time Frame: During the study day, time 0-240 minutes
plasma concentrations of GIP
During the study day, time 0-240 minutes
Ghrelin
Time Frame: During the study day, time 0-240 minutes
plasma concentration of ghrelin
During the study day, time 0-240 minutes
insulin
Time Frame: During the study day, time 0-240 minutes
serum concentration of insulin
During the study day, time 0-240 minutes
free fatty acids
Time Frame: During the study day, time 0-240 minutes
Serum concentrations of free fatty acids
During the study day, time 0-240 minutes
LEAP2
Time Frame: From baseline to end of study day (time 0-240 minutes)
Plasma concentration of liver-expressed antimicrobial peptide 2 (LEAP2)
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)
Plasma concentration of glucagon
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)
Plasma concentration of acetaminophen following oral acetaminophen intake
From baseline to end of study day (time 0-240 minutes)
Energy expenditure
Time Frame: After 60 and approx 180 minutes
Indirect calorimetry
After 60 and approx 180 minutes
Subjective appetite - appetite questionaire
Time Frame: Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes
We will assess subjective appetite sensations on a visual analog score. Scale range from 1 to 10 centimeters.
Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-185-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The corresponding author will make data available on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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