Metabolic Effects of the Exercise-metabolite Lac-Phe

NCT06743009 | Completed

• 1 other identifier: 1-10-72-185-23
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Overweight/Obese

Keywords

Lac-Phe; Appetite; Glucose metabolisme

Outcome Measures

Primary Outcomes (1)

• ad libitum meal test

  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 Outcomes (15)

• 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

Study Arms (2)

Lac-Phe

EXPERIMENTAL

Intravenous infusion of Lac-Phe

Other: N-lactoyl-phenylalanine

Control

PLACEBO COMPARATOR

Intravenous infusion of NaCl

Other: NaCl

Interventions

N-lactoyl-phenylalanine OTHER

Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)

Also known as: Lac-Phe

Lac-Phe

NaCl OTHER

0.9% isotonic NaCl infusion

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

SDCA research laboratory

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

N-lactoyl-phenylalanine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: May 13, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)