Clinical trial NCT06743009: Metabolic Effects of Lac-Phe
Official title: The Metabolic Effects of the Exercise-metabolite N-lactoyl-phenylalanine (Lac-Phe)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Overweight/obese
Keywords: Lac-Phe
Appetite
Glucose metabolisme
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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).
* 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.

Primary outcomes:
measure: ad libitum meal test
timeFrame: From start of lac-phe infusion (0 minutes) to meal test at the end of the study (240 minutes)
Secondary outcomes:
measure: Lac-phe
timeFrame: During the study day, time 0-240 minutes
measure: glucose
timeFrame: During the study day, time 0-240 minutes
measure: lactate
timeFrame: During the study day, time 0-240 minutes
measure: c-peptide
timeFrame: During the study day, time 0-240 minutes
measure: triglycerider
timeFrame: During the study day, time 0-240 minutes
measure: GLP-1
timeFrame: During the study day, time 0-240 minutes
measure: GIP
timeFrame: During the study day, time 0-240 minutes
measure: Ghrelin
timeFrame: During the study day, time 0-240 minutes
measure: insulin
timeFrame: During the study day, time 0-240 minutes
measure: free fatty acids
timeFrame: During the study day, time 0-240 minutes
measure: LEAP2
timeFrame: From baseline to end of study day (time 0-240 minutes)
measure: Glucagon
timeFrame: From baseline to end of study day (time 0-240 minutes)
measure: Gastric emptying assessed by acetaminophen
timeFrame: From baseline to end of study day (time 0-240 minutes)
measure: Subjective appetite - appetite questionaire
timeFrame: Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes
measure: Energy expenditure
timeFrame: After 60 and approx 180 minutes
Other outcomes:
Locations:
Study officials:
References: