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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:
During the study, participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lac-Phe | Experimental | Intravenous infusion of Lac-Phe |
|
| Control | Placebo Comparator | Intravenous infusion of NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-lactoyl-phenylalanine | Other | Intravenous infusion of N-lactoyl-phenylalanine (Lac-Phe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lac-phe | plasma concentrations of lac-phe | During the study day, time 0-240 minutes |
| glucose | plasma concentrations of glucose | During the study day, time 0-240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SDCA research laboratory | Aarhus N | 8200 | Denmark |
The corresponding author will make data available on reasonable request.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000723769 | N-lactoyl-phenylalanine |
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| NaCl | Other | 0.9% isotonic NaCl infusion |
|
| lactate | plasma concentrations of lactate | During the study day, time 0-240 minutes |
| c-peptide | serum concentrations of c-peptide | During the study day, time 0-240 minutes |
| triglycerider | plasma concentrations of triglycerides | During the study day, time 0-240 minutes |
| GLP-1 | plasma concentration of GLP-1 | During the study day, time 0-240 minutes |
| GIP | plasma concentrations of GIP | During the study day, time 0-240 minutes |
| Ghrelin | plasma concentration of ghrelin | During the study day, time 0-240 minutes |
| insulin | serum concentration of insulin | During the study day, time 0-240 minutes |
| free fatty acids | Serum concentrations of free fatty acids | During the study day, time 0-240 minutes |
| LEAP2 | Plasma concentration of liver-expressed antimicrobial peptide 2 (LEAP2) | From baseline to end of study day (time 0-240 minutes) |
| Glucagon | Plasma concentration of glucagon | From baseline to end of study day (time 0-240 minutes) |
| Gastric emptying assessed by acetaminophen | Plasma concentration of acetaminophen following oral acetaminophen intake | From baseline to end of study day (time 0-240 minutes) |
| Subjective appetite - appetite questionaire | We will assess subjective appetite sensations on a visual analog score. Scale range from 1 to 10 centimeters. | Hourly thoughout the study - times 0, 60, 120, 180 and 240 minutes |
| Energy expenditure | Indirect calorimetry | After 60 and approx 180 minutes |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |