Effect of Oral Supplementation With One Form of L-arginine on Vascular Endothelial Function in Healthy Subjects Featuring Risk Factors Related to the Metabolic Syndrome.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Robert Benamouzig
PU-PH in University Hospitals Paris-Seine-Saint-Denis-APHP-University Hospital Avicenne / Jean Verdier
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Physiological assessment of endothelial function in postprandial and fasting (Endothelial function was assessed by flow-mediated dilation (FMD) and peripheral arterial tonometry (EndoPAT)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Asymmetric Dimethyl-L-Arginine (ADMA) measurement(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Amino acids measurement(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Nitrite measurement(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Complete blood count (CBC) analysis(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Insulin and glucose measurement(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Lipid profile analysis(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)
- Metabolomic analysis(Before the supplementation at day 0 and after the supplementation (1month after) at day 29 for each treatment)