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NCT Number: NCT06743009

Metabolic Effects of the Exercise-metabolite Lac-Phe

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

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Key information

Conditions

Healthy Overweight/Obese Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SDCA research laboratory

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-lactoyl-phenylalanine

Other

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

Other names: Lac-Phe

NaCl

Other

0.9% isotonic NaCl infusion

Primary outcomes

  1. 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

  1. Lac-phe

    Time frame: During the study day, time 0-240 minutes

    plasma concentrations of lac-phe

  2. glucose

    Time frame: During the study day, time 0-240 minutes

    plasma concentrations of glucose

  3. lactate

    Time frame: During the study day, time 0-240 minutes

    plasma concentrations of lactate

  4. c-peptide

    Time frame: During the study day, time 0-240 minutes

    serum concentrations of c-peptide

  5. triglycerider

    Time frame: During the study day, time 0-240 minutes

    plasma concentrations of triglycerides

  6. GLP-1

    Time frame: During the study day, time 0-240 minutes

    plasma concentration of GLP-1

  7. GIP

    Time frame: During the study day, time 0-240 minutes

    plasma concentrations of GIP

  8. Ghrelin

    Time frame: During the study day, time 0-240 minutes

    plasma concentration of ghrelin

  9. insulin

    Time frame: During the study day, time 0-240 minutes

    serum concentration of insulin

  10. free fatty acids

    Time frame: During the study day, time 0-240 minutes

    Serum concentrations of free fatty acids

  11. LEAP2

    Time frame: From baseline to end of study day (time 0-240 minutes)

    Plasma concentration of liver-expressed antimicrobial peptide 2 (LEAP2)

  12. Glucagon

    Time frame: From baseline to end of study day (time 0-240 minutes)

    Plasma concentration of glucagon

  13. Gastric emptying assessed by acetaminophen

    Time frame: From baseline to end of study day (time 0-240 minutes)

    Plasma concentration of acetaminophen following oral acetaminophen intake

  14. Subjective appetite - appetite questionaire

    Time frame: Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes

    We will assess subjective appetite sensations on a visual analog score. Scale range from 1 to 10 centimeters.

  15. Energy expenditure

    Time frame: After 60 and approx 180 minutes

    Indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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