Effect of Arginine Supplementation in the Metabolic Syndrome
- Conditions
- OverweightHypertriglyceridemic Waist
- Interventions
- Dietary Supplement: One form of arginineDietary Supplement: placebo
- Registration Number
- NCT02354794
- Brief Summary
The purpose of this study is to determine whether oral supplementation with one form of arginine improves vascular endothelial function in healthy subjects with risk factors associated with the metabolic syndrome
- Detailed Description
The study is a randomized crossover study including 32 subjects with risk factors associated with metabolic syndrome. In a cross-over design, each subject received oral arginine and placebo, in a randomized order, and were studied the day preceding the first day of administration of arginine (or placebo) and after 4 weeks of arginine (or placebo) supplementation. The two periods of supplementation were separated by a washout period of at least 4 weeks.
The subject were studied in the morning (when before supplementation) and in a whole day (when after supplementation).
The mornings cessions consisted of fasting blood draw and vascular explorations, including a measurement of endothelium-dependent brachial artery reactivity ("Flow mediated dilation"), directly coupled to a measurement of post-ischemic digital reactivity (with the Endo-PAT method), completed by a measurement of non-endothelium-dependent brachial artery reactivity. An analysis of the pulse wave geometry was also performed.
The whole-day cession consisted of the same fasting vascular explorations. Blood tests were performed fasting and repeated 2, 4 and 6 h after ingestion of a high-fat meal (900 kcal). Measurements of Flow mediated dilation was repeated 4h and postischemic digital reactivity were repeated 2, 4 and 6 h after ingestion of the high fat meal.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Healthy subjects with 'hypertriglyceridemic waist' One form of arginine Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention: see below Healthy subjects with 'hypertriglyceridemic waist' placebo Subjects with overweight, elevated waist circumference and elevated fasting triglyceridemia. Intervention: see below
- Primary Outcome Measures
Name Time Method Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT) Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT).
FMD technique was used during the fasting test. The RHI measurements were performed the morning fasting and 2, 4, and 6 hours after administration of the high-fat meal, in the case of exploration days after supplementation. In terms of the 4h measurement, it was coupled to a FMD assessment.
FMD was calculated as the percentage change in artery diameter at peak dilation compared with baseline and is reported as a percentage.
The Reactive Hyperemia Index (RHI) was calculated as the ratio of the average pulse wave amplitude during hyperemia (60 to 120 s of the postocclusion period) to the average pulse wave amplitude during baseline in the occluded hand divided by the same values in the control hand and then multiplied by a baseline correction factor.Evaluation of plasma vascular cell adhesion molecule-1 (VCAM-1) of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations of VCAM-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.
Evaluation of plasma intercellular adhesion molecule (ICAM-1) of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations of ICAM-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.
Evaluation of plasma E-Selectin of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations E-Selectin will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Evaluation of plasma Endothelin-1 of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations of Endothelin-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.
Evaluation of plasma P-Selectin of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations P-Selectin will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
Evaluation of plasma Plasminogen activator inhibitor-1 (PAI-1) of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations of 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.
Evaluation of plasma C-reactive protein (CRP) of endothelial function in postprandial and fasting Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting plasma concentrations of CRP will be determined using two custom mixed assay kits with antibody-coated beads using the Luminex xMAP technology platform for multiplexing of immunochemical bioassays.
- Secondary Outcome Measures
Name Time Method Asymmetric Dimethyl-L-Arginine (ADMA) measurement Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment - Fasting ADMA concentrations were measured by an enzyme-linked immunosorbent assay.
Amino acids measurement Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting amino acids contents was assayed by High-performance liquid chromatography (HPLC).
Nitrite measurement Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting nitrite were analyzed by Gas chromatography-mass spectrometry (GC-MS).
Complete blood count (CBC) analysis Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting and postprandial complete blood count (CBC) (was assayed using "classical clinical biochemical analyzers".
Insulin and glucose measurement Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment The fasting insulin and the fasting and postprandial glucose were assayed using "classical clinical biochemical analyzers".
Lipid profile analysis Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment - The fasting lipid profile (triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) and the postprandial evolution of triglycerides were measured and were assayed using "classical clinical biochemical analyzers".
Metabolomic analysis Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment Fasting metabolomic analysis with metabolomic approaches
Trial Locations
- Locations (1)
Centre de Recherche sur Volontaires (CRV), Hospital Avicenne
🇫🇷Bobigny, Ile-de-France, France