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Clinical Trials/NCT06743009
NCT06743009RecruitingNot Applicable

The Metabolic Effects of the Exercise-metabolite N-lactoyl-phenylalanine (Lac-Phe)

University of Aarhus1 site in 1 country24 target enrollmentStarted: May 13, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
ad libitum meal test
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).
  • •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.

Arms & Interventions

Lac-Phe

Experimental

Intravenous infusion of Lac-Phe

Intervention: N-lactoyl-phenylalanine (Other)

Control

Placebo Comparator

Intravenous infusion of NaCl

Intervention: NaCl (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Lac-phe(During the study day, time 0-240 minutes)
  • glucose(During the study day, time 0-240 minutes)
  • lactate(During the study day, time 0-240 minutes)
  • c-peptide(During the study day, time 0-240 minutes)
  • triglycerider(During the study day, time 0-240 minutes)
  • GLP-1(During the study day, time 0-240 minutes)
  • GIP(During the study day, time 0-240 minutes)
  • Ghrelin(During the study day, time 0-240 minutes)
  • insulin(During the study day, time 0-240 minutes)
  • free fatty acids(During the study day, time 0-240 minutes)
  • LEAP2(From baseline to end of study day (time 0-240 minutes))
  • Glucagon(From baseline to end of study day (time 0-240 minutes))
  • Gastric emptying assessed by acetaminophen(From baseline to end of study day (time 0-240 minutes))
  • Subjective appetite - appetite questionaire(Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes)
  • Energy expenditure(After 60 and approx 180 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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