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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00755-38 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Institut de Recherche Pierre Fabre | OTHER |
| Hospital Avicenne | OTHER |
| Adeprina | OTHER |
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The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in healthy subjects featuring metabolic syndrome related risk factors
The study is a randomized crossover study including 16 healthy subjects with risk factors for metabolic syndrome and 16 healthy control subjects. According a double crossover design, each subject received two oral forms of L-arginine (A and B) in random order, and participated in a exploration day on the first day of arginine administration and after one week of supplementation with this arginine form. The two weeks of arginine supplementation were separated by a washout period of 2 weeks at least.
Each exploration extended over 24 hours after administration of the first arginine dose. Blood tests were performed at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 h after administration of the first dose. During explorations after the supplementation period, we also collected urine (0, 2, 4, 8, 12, 24 h after the first dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects with 'hypertriglyceridemic waist' | Experimental | Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine |
|
| Healthy subjects | Experimental | Control subjects, i.e. without overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention : A form arginine and B form arginine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A form Arginine | Dietary Supplement | 3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate of total conversion of a dose of oral arginine into NO | This assessment uses labelled arginine ([15N2-(guanido)]-arginine) for the first dose of arginine taken in the morning, and measurements of 15NO3 in urine for 24h. After administration of 15N-arginine, for each urine collection, we determined the nitrate excretion (from measurement of diuresis and nitrate concentration, by reactive chemiluminescence) and isotope 15N enrichment of nitrate ion (by microdiffusion technique and elementary analyzer connected to an isotope mass spectrometerEA-IRMS), to establish, by the principle of isotopic dilution, the total quantities of nitrate specifically from the ingested arginine. The sum of this excretion relative to the ingested dose determined the relative conversion of ingested arginine into NO. | Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment |
| Estimate of kinetic profiles of plasma arginine concentrations over 24 hours | Plasma AA concentrations were determined using an ultra-performance liquid chromatography-mass spectrometry system as previously described (Haque and al., 2012). | Repeated measurement for 24h before (day 0) and after supplementation (day 8) for each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis of plasma markers of endothelial function | Fasting plasma concentrations of vascular cell adhesion molecule-1 (VCAM-1), intercellular adhesion molecule (ICAM-1), E-Selectin, P-Selectin, Plasminogen activator inhibitor-1 (PAI-1), will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays. In addition, we also have plasma concentrations of nitrite, a marker of of NO production (by reactive chemiluminescence) and other associated markers (3-nitrotyrosine, nitrosothiols, cGMP, in particular ANP, by immunochemistry). |
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Healthy subjects with 'Hypertriglyceridemic waist' :
Inclusion Criteria:
Exclusion Criteria:
Healthy control subjects :
Inclusion Criteria:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Robert Benamouzig | Hospital Avicenne | Principal Investigator |
| François Mariotti, PhD | AgroParisTech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche sur Volontaires (CRV), Hospital Avicenne | Bobigny | ÃŽle-de-France Region | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12660684 | Background | Abdelhamed AI, Reis SE, Sane DC, Brosnihan KB, Preli RB, Herrington DM. No effect of an L-arginine-enriched medical food (HeartBars) on endothelial function and platelet aggregation in subjects with hypercholesterolemia. Am Heart J. 2003 Mar;145(3):E15. doi: 10.1067/mhj.2003.160. | |
| 7560599 | Background | Adams MR, Forsyth CJ, Jessup W, Robinson J, Celermajer DS. Oral L-arginine inhibits platelet aggregation but does not enhance endothelium-dependent dilation in healthy young men. J Am Coll Cardiol. 1995 Oct;26(4):1054-61. doi: 10.1016/0735-1097(95)00257-9. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D064250 | Hypertriglyceridemic Waist |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| B form Arginine | Dietary Supplement | 3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week |
|
| Before supplementation (day 0) and after supplementation (day 8) for each treatment |
| Estimate of kinetics use of arginine for NO and urea synthesis | After administration of 15N-arginine, we measured 15N isotopic enrichment of arginine and citrulline (by mass spectrometry coupled with gas chromatography), of plasma and urinary urea (by separation, by ion exchange, and EA-IRMS) as well as the plasma and urine concentrations in urea. These data and those of arginine and citrulline concentrations provided, by the principle of isotopic dilution, the plasma appearance of ingested arginine and the plasma appearance and urinary excretion of products of its metabolism in NO synthase and arginase ways. These data were then subjected to a compartmental modeling work to establish the metabolic flow in these ways. | Repeated measurement for 24h after supplementation (day 8) for each treament |
| Other quantitative analysis |
| Before supplementation (day 0) and after supplementation (day 8) for each treatment |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015228 | Hypertriglyceridemia |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |