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

University of Aarhus1 site in 1 country24 target enrollmentMay 13, 2025

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: University of Aarhus
Enrollment: 24
Locations: 1
Primary Endpoint: ad libitum meal test
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

May 13, 2025

End Date

January 1, 2027

Last Updated

8 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility Criteria

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.

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)