Metabolic Effects of Lac-Phe

University of Aarhus

Status: Not yet enrolling

Conditions: Healthy Overweight/obese

Treatments: Other: N-lactoyl-phenylalanine; Other: NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT06743009

1-10-72-185-23

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

Lac-Phe

Experimental group

Description:

Intravenous infusion of Lac-Phe

Treatment:

Other: N-lactoyl-phenylalanine

Control

Placebo Comparator group

Description:

Intravenous infusion of NaCl

Treatment:

Other: NaCl