Metabolic Effects of Lac-Phe

Not Applicable

Not yet recruiting

• Conditions: Healthy Overweight/obese

• Registration Number: NCT06743009
• Lead Sponsor: University of Aarhus

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-03-01
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
ad libitum meal test	From start of lac-phe infusion (0 minutes) to meal test at the end of the study (240 minutes)	Meal intake (kcal) during the ad libitum meal test

Secondary Outcome Measures

Name	Time	Method
Glucagon	From baseline to end of study day (time 0-240 minutes)	Plasma concentration of glucagon
insulin	During the study day, time 0-240 minutes	serum concentration of insulin
free fatty acids	During the study day, time 0-240 minutes	Serum concentrations of free fatty acids
LEAP2	From baseline to end of study day (time 0-240 minutes)	Plasma concentration of liver-expressed antimicrobial peptide 2 (LEAP2)
Lac-phe	During the study day, time 0-240 minutes	plasma concentrations of lac-phe
glucose	During the study day, time 0-240 minutes	plasma concentrations of glucose
lactate	During the study day, time 0-240 minutes	plasma concentrations of lactate
c-peptide	During the study day, time 0-240 minutes	serum concentrations of c-peptide
triglycerider	During the study day, time 0-240 minutes	plasma concentrations of triglycerides
GLP-1	During the study day, time 0-240 minutes	plasma concentration of GLP-1
GIP	During the study day, time 0-240 minutes	plasma concentrations of GIP
Ghrelin	During the study day, time 0-240 minutes	plasma concentration of ghrelin
Gastric emptying assessed by acetaminophen	From baseline to end of study day (time 0-240 minutes)	Plasma concentration of acetaminophen following oral acetaminophen intake
Subjective appetite - appetite questionaire	Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes	We will assess subjective appetite sensations on a visual analog score
Energy expenditure	After 60 and approx 180 minutes	Indirect calorimetry