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This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of DHA-NAT (C22:6 N-acyl taurine, an endogenous metabolite derived from the omega-3 fatty acid, docosahexaenoic acid) on postprandial plasma triglyceride levels following a high-fat meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA-NAT | Experimental | Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. |
|
| Placebo | Placebo Comparator | Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA-NAT | Other | Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma triglyceride | Change in incremental area-under-curve plasma triglyceride | 0-240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GLP-1 | Plasma GLP-1 profile | 0-240 minutes |
| Plasma N-acyl taurine species | Profile of plasma n-acyl taurine species | 0-240 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research, Herlev-Gentofte Hospital | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Other | Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT). |
|
| Plasma ApoB48 | Plasma ApoB48 profile | 0-240 minutes |
| Satiety, hunger and appetite | Development during study day recorded by visual analogue scale (VAS), 0-10 cm where 0 = not in agreement with statement and 10 = in agreement with statement. | 0-240 minutes |
| Food intake (g) | Grams consumed of a standard ad libitum meal | t=240 minutes |
| Food intake (kcal) | kcal consumed of a standard ad libitum meal | t=240 minutes |
| Plasma triglyceride (TG) distribution | total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG | 0-240 minutes |
| Plasma free fatty acid species | Total fatty acids profile | 0-240 minutes |
| Plasma cholesterol | Total cholesterol, HDL, LDL, VLDL, remnant cholesterol | 0-240 minutes |
| Plasma level of glucose regulating hormones | Insulin, glucagon and gastric inhibitory polypeptide | 0-240 minutes |
| Plasma amino acids | Total amino acids profile | 0-240 minutes |
| Plasma glucose | Plasma glucose profile | 0-240 minutes |
| Plasma bile acid species | Plasma bile acid profile | 0-240 minutes |
| Gall bladder emptying: Cholecystokinin | Cholecystokinin profile | 0-240 minutes |
| Gall bladder emptying: Ultrasonography | Difference in volume from most to least full | 0-240 minutes |
| Gastric emptying: Paracetamol | Plasma acetaminphen profile | 0-240 minutes |
| Stool quality | Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid) | Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours. |
| D009750 |
| Nutritional and Metabolic Diseases |