Healthy Overweight/Obese
Conditions
Keywords
Lac-Phe, Appetite, Glucose metabolisme
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
Interventions
OTHERN-lactoyl-phenylalanine
Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe)
OTHERNaCl
0.9% isotonic NaCl infusion
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ad libitum meal test | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Glucagon | From baseline to end of study day (time 0-240 minutes) | Plasma concentration of glucagon |
| 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. Scale range from 1 to 10 centimeters. |
| Energy expenditure | After 60 and approx 180 minutes | Indirect calorimetry |
Countries
Denmark
Outcome results
None listed